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AIG on REACH 3.1
Contents
3
Executive Summary 4
Foreword: About this Guideline 7
List of Annexes 80
4 Executive Summary
In preparation for REACH, representatives of all the • Depending on the role(s) they perform in REACH,
major vehicle manufacturers and the automotive companies should have an inventory of the sub-
supply chain formed a Task Force on REACH (TF- stances/mixtures/articles they use. This will help to
REACH). The TF-REACH recommends a common assess their obligations and next steps.
schedule and external communication strategy which
harmonises the sector’s response to REACH and avoids • Downstream users expect their uses of a substance to
duplication and confusion. The TF-REACH approach be registered up the supply chain.
and recommendations are outlined in this Automotive
Industry Guideline on REACH (AIG). • The AIG makes the recommendation that non-EEA
suppliers appoint an Only Representative in the EEA
Since the publication of the Automotive Industry which takes on the importer responsibilities, instead
Guideline (AIG) on REACH Version 2.1 in May 2008 the of each of their customers duplicating the importer
REACH process has passed some important milestones role (see Chapter 5.4).
such as pre-registration, the first publication of a
Candidate List ( hereinafter CL) with SVHC, Annex XIV • To fulfil their REACH obligations, the entire supply
Authorisation List and most importantly the first chain needs to communicate data, uses, control mea-
registration deadline at the end of 2010. Having sures for safe use, etc. (see Chapter 5.5 and the stan-
accumulated a wealth of experience through the dard REACH awareness letter in Annex B).
cooperation in the Task Force and in the light of
upcoming processes which include authorisation • Each actor in the supply chain should appoint a
of use, notification of CL substances in articles and REACH representative and develop a strategic action
communication due to the steadily increasing CL, it plan to ensure compliance and minimise the business
was felt that an update of the AIG would be helpful for risks posed by REACH.
vehicle manufacturers and the automotive industry
supply chain. • Thesector has considered whether any substance
AIG on REACH 3.1
Disclaimer
This document contains guidance explaining the REACH obligations for the automotive industry and how to
fulfil them. It is offered in good faith and reflects the best knowledge of the Global Automotive Industry experts
and the state of the art at the time of its publication. However, users are reminded that the text of the REACH
regulation is the only authentic legal reference and that a binding interpretation of Community legislation is
the exclusive competence of the European Court of Justice. Therefore the information and guidance in this
www.acea.be/reach
document are not legally binding. The Associations responsible for the publication of this document will not
accept any liability regarding the contents of this document or arising from its use.
The Associations are committed without reservation to fair competition. As Trade Associations, their purpose
is to promote the interest of their members and to facilitate their respective aims and objectives only through
legitimate means and activities. In carrying out this role, the Associations shall proceed with caution to ensure
against violation of anti-trust.
16 April 2012
Foreword: About this Guideline
7
This Introduction explains why the automotive industry To accomplish these realities and to fulfil the aims and
needs such guidelines but will not give a complete objectives, REACH requires action from the Automotive
overview of “What is REACH?” OEMs and suppliers immediately and in the future.
The REACH Regulation3 was adopted into European When registration is considered, one has to be assured
Union (EU) law in December 2006 and came into force that all business relevant substances on their own or
on 1 June 2007. As an EC regulation, it automatically in mixtures are or will be registered for your specific
becomes law in each Member State, so it does not need use by a supplier. For non-EEA suppliers it is highly
transposition in the same way as a directive. However, recommended to appoint an OR in the EEA to take on
each Member State is obliged to enforce REACH under the responsibilities of an importer. In this case, non-
consideration of the individual national legislation EEA suppliers can continue to deliver into the EEA
scheme. without each of their customers becoming importers
under REACH.
REACH Realities
As well as registration, REACH includes a number of
• REACH is not just a chemical industry issue as it other obligations that require the automotive industry,
impacts producers or importers of articles. to adopt processes and tools already in existence as
• REACH is not only an EU-based company issue. well as the implementation of new practices.
• REACH is not only an issue for environmental, health
and safety specialists.
Obligations
• Companies that do not comply with REACH will have
no market. REACH poses a threat to any company do- REACH puts the responsibility on industry to provide
ing business in the EEA (and businesses with custom- safety information for substances and to properly
ers or suppliers who do business in the EEA). manage the risks arising from their use. Under
• Business continuity can be adversely impacted by the previous regime, the burden of proof was on
REACH and supply chains can be disrupted. governments to prove substances were unsafe and to
• Companies that understand the business implica- restrict their use. REACH covers all substances on their
tions and impacts of REACH and develop strategic own, in mixture and in articles, but there are exemptions
action plans will gain competitive edge over those for radioactive substances, non-isolated intermediates,
that do not. substances used during transportation, and waste
• Substitutions need to be phased-in with product de- (Article 2 REACH). These are covered by other existing
velopment programmes to minimise cost. regulations. Member States may also grant exemption
for substances used in the interest of defence.
Aims of REACH
Under REACH, manufacturers and importers have a
REACH aims to ensure a “high level of protection of duty to register, for each legal entity, substances on
human health and the environment, including the their own, or in mixtures that they produce or import in
AIG on REACH 3.1
promotion of alternative methods for assessment of quantities over 1 tonne per year (per legal entity), unless
hazards of substances, as well as the free circulation of the substance is exempt from registration. Registration
substances within the internal market while enhancing requirements also apply to substance(s) intended to
competitiveness and innovation” (Article 1.1 REACH). be released from articles under certain conditions, in
which case the article producer/importer is responsible
The main objectives of REACH are therefore: for ensuring that the substances are registered. To fulfil
• To reduce the risk from chemicals to humans and the these obligations, the entire supply chain needs to
environment and to reduce animal testing. communicate (data, uses, quantities, control measures
• To encourage substitution of specific dangerous sub- for safe use, etc.). Downstream users have a specific
stances, listed in REACH Annex XIV and XVII. set of duties and obligations under REACH and will
• To require authorisation for use or restriction of the have to work closely with their suppliers to have their
substances mentioned in Annex XIV and XVII identified uses registered.
9
Each player in the supply chain should develop a strategic restriction, classification and labelling of dangerous
action plan (see Chapter 6) to ensure compliance and substances that were amended in 2008. The
minimise the business risks posed by REACH. Classification, Labelling and Packaging Regulation
(CLP Regulation (EC) No 1272/20084) as the European
The automotive industry includes producers of implementation of the United Nations (UN) Globally
articles (e.g. car, engine, bumper), importers of articles Harmonised System for Classification and Labelling of
(e.g. screw from China), importers of mixtures (e.g. Chemicals (GHS) is leading to further adaptations of
engine oil from USA) and importers of substances REACH that are also impacting the automotive industry,
(e.g. elemental Magnesium from Australia). Article e.g. with additional obligations in regard to notification
producers and article importers have specific and safety data sheets.
obligations under REACH, in particular the registration
of substances intended to be released from articles and
REACH Review
the communication/notification to downstream users
and ECHA of CL substances present in the article under Article 138(6) REACH calls on the Commission to carry
certain conditions. Under REACH it is not required to out a review by 1 June 2012 to assess whether or not to
register or to notify ECHA of substances in articles if amend the scope of REACH to avoid overlaps with other
they are already registered for that use. However, the relevant Community provisions. On the basis of such
presence of CL substances must be communicated to review, the Commission may, if appropriate, present a
downstream users in this case. legislative proposal.
Note
»»Companies that import substances or mixtures
from outside the EEA are no longer considered
to be downstream users but Importers and have
to comply with the Importer’s obligations under
REACH.
»» Companies that produce articles that intention-
ally release substances are not acting as down-
stream users and may have registration obliga-
tions if this use has not been already registered.
»» Substances or mixtures that were originally pro-
duced (and the registration has been completed)
in the EEA and which have been re-imported to
the EEA are considered as being registered.
Manufacturer/Importer
Formulator 2
Distributor Consumer
Exposure scenario
means “the set of conditions, including operational
conditions and risk management measures, that
describe how the substance is manufactured or used
during its life-cycle and how the manufacturer or
5
Beside Exposure Scenarios for substances, the ECHA
importer controls, or recommends Downstream Users
guidance document also describes Exposure Scenarios for
to control exposure to humans and the environment. mixtures. However, according to the legal REACH text, there
These exposure scenarios may cover one specific are no exposure scenarios for mixtures. The automotive
industry therefore decided not to put “mixtures” into this
process or use, or several processes or uses as definition. For further information and explanation please
appropriate” (Article 3.37 REACH). visit AIG Chapter 5.5.
12
2.1
Exporters
Importers
teria as being hazardous according to Regulation (EC) additional attribute. If a release is incidental, this is not
No 1272/2008 (on classification, labelling and an intended release. In cases where an intended release
packaging of substances and mixtures, so-called “CLP”). of substances is the main function of an object, it is to
Annex I, parts 2 to 5, therein describe the criteria be regarded as a container with substances/mixtures
making a substance hazardous. inside but not an article.
Basic criterion: Does the Article still work without the
Identified use release? If yes, the release is not intended.
means “a use of a substance on its own or in a A list of automotive industry specific examples of
mixture, that is intended by an actor in the supply intended release is given in Chapter 5.7.
chain, including his own use, or that is made known A release is not considered to be an intended release in
to him in writing by an immediate Downstream User” the following cases:
(Article 3.26 REACH).
13
an agreement and the abilities to assume an obligation pdf/nanomaterials.pdf contains useful information for
and to pay off its debts. A legal entity under the law companies in the automotive chain that today already
is responsible for its` actions and can be sued for have to deal with nanomaterials under REACH.
damages.
Non phase-in substance
Manufacturer means “a substance which does not meet the criteria of
means “any natural or legal person established within phase-in substance” (defined below); that is, a substance
the Community who manufactures a substance within which was not manufactured, marketed, or put on the
the Community”. (Article 3.9 REACH) market prior to the entry into force of REACH.
Example: ethanol manufacturer, copper manufacturer
14
2.1
REACH cannot weaken international Conventions and and is now called “EC-number”. There are currently
other existing EU legislation, REACH Authorisation 100,204 entries.
cannot be granted for a substance that has been ELINCS
officially classified as a POP under Regulation (EC) No (European List of Notified Chemical Substances)
850/2004 or one of its later amendments. is a list of substances having become commercially
Reference is made to POPs in Article 61.6 of REACH available after 18 September 1981. They were
where it states “If a use of a substance is subsequently already notified under Article 8(1) of Directive
prohibited or otherwise restricted in Regulation 67/548/EEC amended by Directive 79/831/EEC and
(EC) No 850/2004 of the European Parliament their identifying number is called “ELINCS number”.
and of the Council of 29 April 2004 on persistent Such substances have an official notification
organic pollutants, the Commission shall withdraw number (ELINCS) mainly starting with digit “4”.
the authorisation for that use”. If an exemption is These ELINCS substances are considered registered
15
under REACH. The final edition of ELINCS (2009) the requirement that they were considered to be
is comprehensive and contains 8433 notifications, polymers under the reporting rules for EINECS but
representing 5292 substances in total. are no longer considered to be polymers as from the
Both lists are accessible via: 92/32/EEC). The no-longer polymer list contains
http://esis.jrc.ec.europa.eu only substances not included in EINECS. The list is
not exhaustive. Please note in this connection that the
notification to the NLP list was on a voluntary basis
Placing on the market and since there were not many registrants making
means “supplying or making available, whether in use of this there are many tensides that do neither
return for payment or free of charge, to a third party. have an EC nor an NLP number. Therefore dummy EC
Import shall be deemed to be placing on the market.” numbers were allocated to them starting with “600”.
(Article 3.12 REACH). http://esis.jrc.ec.europa.eu
Producer of an article
means “any natural or legal person who makes or Predicted No Effect Concentration (PNEC)
assembles an article within the Community” means the concentration of a substance below which
(Article 3.4 REACH). adverse effects in the environmental compartment of
Example: Vehicle manufacturer, parts manufacturer concern are not expected to occur.
(e.g. engine, component, bolt)
Product and process orientated research
Polymer and development (PPORD)
means “a substance consisting of molecules characterised means “any scientific development related to product
by the sequence of one or more types of monomer units. development or the further development of a substance,
Such molecules must be distributed over a range of on its own, in mixtures or in articles in the course of
molecular weights wherein differences in the molecular which pilot plant or production trials are used to
weight are primarily attributable to differences in the develop the production process and/or to test the fields
number of monomer units”. (Article 3.5. REACH) of application of the substance” (Article 3.22 REACH).
A polymer comprises the following:
a) a simple weight majority of molecules containing at Recipient of an article
least three monomer units which are covalently bound means “an industrial or professional user, or a
to at least one other monomer unit or other reactant; distributor, being supplied with an article but does not
b) less than a simple weight majority of molecules of include consumers” (Article 3.35 REACH).
the same molecular weight. In the context of this
definition a “monomer unit” means the reacted form Note
of a monomer substance in a polymer. In the automotive industry, customers can
Example: PP, PA6, PVC, POM, PTFE, EPDM, SBR, be consumers or recipients of an article. The
NBR, ECO, etc. customer is considered a consumer, if he or she
buys a regular vehicle which will not be used for
Note any professional business. On the other hand, the
www.acea.be/reach
So-called “no-longer polymers” (NLP) do also exist. customer is regarded as a recipient of an article if
Polymers were not reportable in the past and he or she buys a commercial vehicle like a taxi or
therefore not included in EINECS. In the 7th truck. When spare parts are sold , customers can
amendment (92/32/EEC) to Directive 67/548/ be also of both types, consumers or professional
EEC the term polymer was further defined with users. When selling spare parts for commercial
the consequence that some substances ceased vehicles the customer is generally regarded as
being considered as polymers (i.e. no-longer recipient of an article and not a consumer.
polymers). The NLP list had been created showing
6
Notification under former Directive 67/548/EEC (Directive
substances having been on the EU market between on Classification, Labelling & Packaging of dangerous sub-
18 September 1981 and 31 October 1993 (fulfilling stances). There is no link to the REACH or CLP notification.
16
2.1
Registrant Substance
means “the manufacturer or the importer of a substance means “a chemical element and its compounds in the
or the producer or importer of an article submitting a natural state or obtained by any manufacturing process,
registration for a substance” (Article 3.7.REACH). including any additive necessary to preserve its stability
and any impurity deriving from the process used, but
Registrant’s own use excluding any solvent which may be separated without
means “an industrial or professional use by the affecting the stability of the substance or changing its
registrant” (Article 3.25 REACH). composition” (Article 3.1 REACH).
Example: methane, hydrocarbons, sulphuric acid,
Re-import ethanol, calcium carbonate, silicon dioxide, elemen-
means where a substance is first manufactured in tal metals (e.g. copper, aluminium)
the EEA, then exported (e.g. to be formulated into a (Detailed information on identification and naming of
mixture) and then brought back into the EEA again Substances in REACH can be found in the “Guidance for
(e.g. to be marketed or for further processing). Such identification and naming of substances under REACH”).
re-imports are exempted from registration under the
following conditions: Substances of very high concern (SVHC)
• the substance must have been registered before it The following substances are considered of very high
was exported from the EEA concern according to Article 57 REACH:
• the substance already registered and exported must a) Substances meeting the criteria for classification as
be the same, ie must have the same chemical identity carcinogenic, mutagenic, or toxic for reproduction ac-
and properties as the substance being re-imported cording to Directive 67/548/EEC (“CMR-substances”)
on its own or in mixture (the re-importer has to be category 1a or 1b.
able to prove that the substance is still the same) b) Substances which are persistent, bioaccumulative
• Re-importer must have been provided with informa- and toxic according to Annex XIII REACH (“PBT-sub-
tion on the exported substance (Article 2.7c REACH, stances”).
Guidance on Registration, item 1.6.4.6) c) Substances which are very persistent and very bioac-
cumulative according to Annex XIII REACH (“vPvB-
Scientific research and development substances”).
means “any scientific experimentation, analysis d) Substances which have endocrine-disrupting, per-
or chemical research carried out under controlled sistent, bioaccumulative and toxic or very persistent
conditions in a volume less than 1 tonne per year“ and very bioaccumulative properties, which give rise
(Article 3.23 REACH). to an equivalent level of concern to those of other
substances listed in points (a-c) and which are iden-
Specific Environmental Release Categories tified on a case-by-case basis in accordance with the
(SpERC) procedures set out in Article 59 REACH.
are required for obtaining more realistic 1 tier emission
AIG on REACH 3.1
Supplier of an article
means “any producer or importer of an article,
distributor or other actor in the supply chain placing an
article on the market” (Article 3.33 REACH).
Use
means “any processing, formulation, consumption,
storage, keeping, treatment, filling into containers,
transfer from one container to another, mixing,
production of an article or any other utilization”
(Article 3.24 REACH).
www.acea.be/reach
18 2.2 Acronyms & Initialisms
2.2
ACEA EEA
European Automobile Manufacturers Association European Economic Area
AIAG EINECS
Automotive Industry Action Group European Inventory of Existing Commercial Chemical
Substances
AIG
Automotive Industry Guideline on REACH ELINCS
European List of Notified Chemical Substances
CAS
Chemical Abstracts Service. The CAS number is a means ELV
to identify the substance. End-of-Life Vehicle Directive (2000/53/EC)
CEFIC EPER
European Chemical Industry Council (Conseil Européen European Pollutant Emission Register
de l’Industrie Chimique) http://www.eea.europa.eu/data-and-maps/data/
eper-the-european-pollutant-emission-register-4
CLEPA
European Association of Automotive Suppliers ERC
Environmental Release Categories
CLP
Regulation (EC) No 1272/2008 on classification, labelling ES
and packaging of substances and mixtures Exposure Scenario
CL-Substance GADSL
Substances added to the Candidate List for Authorisa- Global Automotive Declarable Substance List.
tion or Annex XIV REACH See http://www.gadsl.org
CMR GES
Carcinogenic, Mutagenic, Toxic for Reproduction Generic Exposure Scenario
CSR GHS
Chemical Safety Report Globally Harmonised System for classification and
labelling of chemicals
DNEL http://ec.europa.eu/enterprise/reach/ghs_en.htm
Derived No Effect Level
IMDS
AIG on REACH 3.1
ECHA IUCLID
European Chemical Agency International Uniform Chemical Information Database
EDAS JAMA
Electronic data exchange of safety data sheets. It is an Japan Automobile Manufacturers Association, Inc.
interface for structured data exchange on XML format
basis. KAMA
Korea Automobile Manufacturers Association
19
MACSI SDS
Material Composition Information System Safety Data Sheet – eSDS: extended Safety Data Sheet
(PSA system for material declaration)
SIEF
NGO Substance Information Exchange Forum
Non-Governmental Organisation
SMMT
OC Society of Motor Manufacturers and Traders, UK
Operational Conditions
SpERC
OEM Specific Environmental Release Categories
Original Equipment Manufacturer
(Here in most cases the vehicle manufacturer) SVHC
Substance of Very High Concern
OSOR
One Substance, One Registration TARIC
Tarif intégré des Communautés européennes (Integrated
OR Community Taxation & Customs Tariff) is designed to
Only Representative show the various rules applying to specific products
when imported into the EU.
ORGALIME
The European Engineering Industries Association TGD
Technical Guidance Document
PBT (Resulting documents from a RIP)
Persistent, Bio-accumulative and Toxic
TPA
PNEC Tonnes per annum
Predicted No Effect Concentration
VDA
PPORD German Automotive Industry Association
Product and Process Oriented Research and Develop-
ment vPvB
very Persistent and very Bioaccumulative
PRTR
Pollution Release and Transfer Register
REACH
Registration, Evaluation, Authorisation (and Restriction)
of Chemicals
www.acea.be/reach
RMM
Risk Management Measures
RRR
Directive on the type-approval of motor vehicles
with regard to their reusability, recyclability and
recoverability (2005/64/EC)
20 Chapter 3: Important Dates and Deadlines
to Remember
3
2011
By 1 June 2011 • Notification of substances in articles (Article 7.2 REACH) which were included into
the CL before 1 December 2010.
• ECHA will accept notification before 1 June 2011.
Warning: Information requirements to downstream users (Article 33 REACH) apply as
of inclusion on the CL
As from 1 June 2011 • Notification of substances in articles 6 months after they have been included in the
CL (Article 7.8 REACH).
2012
Until 31 May 2012 • DU to make their use(s) known (in writing) to the substance supplier in order to make it
an identified use (Article 37.3 REACH)
As of 1 December 2012 • The use of the new CLP safety data sheet format is obligatory for substances.
2013
Until 31 May 2013 • Registration of substances on their own, in mixtures or intended to be released from
articles in quantities of 100-1000 tpa per manufacturer/importer
(Article 23.2 REACH).
• Safety data sheets for registered substances shall be extended with exposure
scenarios for all identified uses (Article 14 REACH).
2015
As 1 June 2015 • New CLP labelling and safety data sheet format is obligatory for mixtures.
• Directives 67/548/EWG and 1999/45/EG are withdrawn.
2017
Until 31 May 2017 • DU to make their use(s) known in writing to the substance supplier in order to make
it an identified use (Article 37.3 REACH)
As of 1 June 2017 • End of transition period for mixtures in warehouses with old CLP labelling.
2018
Until 31 May 2018 • Registration of substances on their own, in mixtures or intended to be released from
articles in quantities of 1-100 tpa per manufacturer/importer (Article 23.3 REACH).
AIG on REACH 3.1
• Safety data sheets for registered substances shall be extended with exposure sce-
narios for all identified uses (Article 14 REACH).
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Pre-Registration
Registration of Phase-in substances above 1000 tpa & CMR, R50/53 above 100 tpa & Substances for Authorization
Registration of Phase-in substances above 100 tpa
Registration of Phase-in substances above 1 tpa
Registration of non Phase-in substances and not pre-registered substances above 1 tpa
Candidate list (revisions)
Communication of Candidate list substances present in articles to downstream users/consumers (Art. 33)
REACH
Restrictions for the manufacture, use or placing on the market of substances (Art. 68)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
www.acea.be/reach
21
Chapter 4: REACH Compliance -
a Step-by-Step Process
23
The following flow charts have been constructed to help companies determine what their obligations are under REACH.
Flow charts 1 to 8 should be viewed as complimenting each other. Where such guidelines exist, references to them have
been integrated in the flow charts and the AIG 5 step compliance schedule (Chapter 6).
For the following REACH tasks, a flowchart has been developed. To directly jump into a specific subject, you can click
on one of them in the list below:
4.3 REACH Flow Chart 3 Registration of Substances intended to be released from Articles
www.acea.be/reach
24 4.0 Flow Chart Navigator
4.0
Flow Chart 0
Flow Chart Navigator
YES NO
ªªChapter 5.12 Are you affected by Annex
XVII of REACH (Restriction)?
YES NO
ªªChapter 5.4 Do you import substances
on their own, in mixtures or in articles
from outside EEA?
None of your suppliers need to
Flow Charts 5, 6
establish an OR in EEA
Articles
YES Are there NO
ªªChapter 5.9, 5.10 CL-Substances in the articles
you produce or import into
the EEA? (Art. 57)
Flow Charts 4, 8 Currently no notification or
communication obligations
AIG on REACH 3.1
Do you
YES produce articles in or NO
ªªChapter 5.8 import articles into the EEA that
intentionally release substances under
normal and foreseeable
conditions of
Flow Chart 3 use? No registration obligations
ªªChapter 5.15
NO YES
Are the substances/
substances in mixtures exempted
from registration?
ªªChapter 5.2
YES NO
Check
Flow Do you import
No registration obligations
Chart 5 substances at >1 tpa?
YES NO
Is there an alternative
supplier who will register?
YES NO
Will the supplier cover
your use in his registration file? (Art. 37)
ªªChapter 5.5, 5.6, 5.9
YES NO
Is there an
alternative supplier who will cover
your use?
alternative
ªªChapter 5.6
Carry out your own Chemical
www.acea.be/reach
7
Registration obligation of manufactures of substances is not reflected in the AIG and its flowcharts
26 4.2 REACH Authorisation Procedures
4.2
Flow Chart 2
REACH Authorisation procedure
YES Do you NO
produce articles in EEA or Monitor the process prior to
use, produce or import substances or inclusion of substance in
mixtures that contain Annex XIV Annex XIV
substances?
ªªChapter 5.11
NO YES
Is your use confidential?
YES NO
Will you/your supplier
apply for the authorisation
of your use?
Do you
YES produce articles in or NO
ªªChapter 5.8 import articles into the EEA that
intentionally release substances under
normal or reasonably foreseeable
Check conditions of
Flow
Charts use?
5, 6
ªªChapter 5.3
YES NO
Are the substances
in articles subject to registration
obligation?
ªªChapter 5.2
No registration required
YES NO
Has the substance in
the article been registered for that use
(Art. 7.6)?
Check
Flow
Charts
ªªChapter 5.5, 5.9 1,5
8
The total amount of a substance that is intended to be released under normal or reasonably foreseeable conditions of use
from all articles that are produced and/or imported by one actor, including the total volume of the same substance that is not
intended to be released from the articles, must be included in the yearly tonnage calculation.
28 4.4 REACH Notification of Substances in Articles
4.4
If production or import of the
articles stopped before the Flow Chart 4
substance was placed on the Notification of substances in articles
CL they are not subject to
notification even if it is found that
the concentration and tonnage
thresholds were exceeded at Do you
the time of production. If the YES NO No notification is required. If you
produce articles in start to produce or import articles
production or import of articles the EEA or import them from outside
starts before the substance is the EEA containing CL substances? you should proceed to monitor the
included in the CL and ends after- (Art. 57) CL and the Registry of Intentions
wards, those articles produced (ROI) (see Art. 58.3)
or imported before inclusion of
the substance in the CL are not ªªChapter 5.3
subject to notification. ªªChapter 5.9, 5.10, 5.11
Does the
YES fact sheet including the NO
TF-recommendation reflect the outcome Inform the TF immediately under
of your internal inventory results for the reach@acea.be for any needed
use of the CL-Substances in modification of the fact sheet
your articles?
ªªChapter 5.3
YES NO
Is the use of the
No notification is required CL-Substance in your produced or
imported articles registered?
Can risk of
YES exposure to human and NO
to environment during normal and
foreseeable conditions of use including
disposal be excluded
Art.7.3)?
No notification is required Notify the presence of the
butsupply instructions to recipient substance in an article
of the article to avoid exposure yyuntil 1 June 2011 if the SVHC
(Art. 7.3) was placed on CL before
1 Dec 2010
yynot later than 6 month after the
SVHC was placed on CL if
Working assumptions: see AIG Chapeter 5.9 “Notification of CL Substances in Articles” placed there after 1 Dec 2010
4.5 Use of the Only Representative
29
Flow Chart 5
Use of an Only Representative (OR)
ªªChapter 5.3
YES NO
Are the
No registration obligations substances/substances in mixtures
exempted from registration
or <1tpa?
ªªChapter 5.2
YES NO
Does your non-
EEA supplier have an OR (Art. 8)
in the EEA?
Priority 1
Ask non-EEA supplier to
establish an OR in Europe
YES NO
Has the non-
EEA supplier established an OR after
your request?
Priority 2 9
Change your supplier or substitute
the substances/mixtures
9
The order of Priority 2 & 3 is not fixed but depends on the company specific policies and strategies.
30 4.6 Obligations for Importers
4.6
Flow Chart 6
Obligation for Importers
YES NO
ªªChapter 5.4 Are you an importer
of substances and/or substances
Check in mixtures?
Flow
Charts
1, 2, 5
ªªChapter 5.3
YES NO
Are you
No obligations apply
an importer of articles ?
Check YES NO
Flow Does the
Chart 3 article intentionally release
substances > 1 tpa?
Check YES NO
Flow Does the article
Chart 7 contain substances listed on
AIG on REACH 3.1
Annex XVII?
ªªChapter 5.12
4.7 REACH Restriction
31
Flow Chart 7
REACH Restriction procedure
No restriction is applying
ªªChapter 5.3
Do the
Restriction is applying – YES conditions of restriction NO
The product must no longer indicated in Annex XVII apply to
contain the hazardous the product that you place on the market No restriction is applying
substance after the date or to the use of the
stipulated in Annex XVII substance/substance
in mixtures?
www.acea.be/reach
32 4.8 REACH Article 33 Communication
4.8
Flow Chart 8
REACH Art 33 Communication Process
YES NO
No Art. 33 Assumption: CL-substance
communication obligations below (<) 0,1% w/w?
ªªChapter 5.10
YES NO
Is information
complete/plausible?
ªªAnnex D, Q11, Q 16
YES NO
Is information Own data evaluation11
complete/plausible? and document your actions
YES NO
Transmission to professional Does article contain
recipient of the article and archive CL-Substance > 0,1% w/w ?
communication (Art. 33.1)
Check
AIG on REACH 3.1
Flow
Chart 4
YES NO
Provide information within Did (private) consumer ask for No Art. 33
45 days after written request Art. 33.2 information? communication obligations
10 zzInformation on CL-substance > 0.1% w/w should be delivered automatically by your supplier with the article
(e.g. IMDS Material Data Sheet)
zzFor in house manufactured parts the same information has to be available
YES NO
Do you handle
Substances and/or Mixtures in No SDS obligations
your business?
ªªChapter 5.3
ªªChapter 5.6.2
ªªChapter 5.7
YES NO
Is the amount of
substances/substances in
mixtures > 10 tpa?
Your supplier has to provide you
Your supplier has to provide
an extended SDS including
you a normal SDS
Exposure Scenarios12
ªªChapter 5.5, 5.6
Please note that exposure scenario only exist for substances not for mixtures, but you may receive a consolidated safety assess-
12
“REACH distinguishes the following actors in the supply For further explanation, please check Chapter 2.1 “Main
chain and defines them as follows: Definitions”
• Downstream user
• Exporter NOTE
• Manufacturer Automotive industry companies play several
• Importer roles under REACH and have specific obligations,
• Producer of articles depending on whether they:
• Recipient of articles
• Supplier of articles
Formulate (Manufacture)
In this case companies bear the obligations of DUs See Chapter 5.5
Mixtures
Use substances/mixtures
In this case companies bear the obligations of DUs See Chapter 5.5
supplied by an EEA supplier
It is important to note for downstream users that In cases where the article producer/importer
substances that may result from a chemical reaction subcontracts a certain treatment of the article to
acting upon the end use of other substances, mixtures a second company (e.g. for surface treatment), the
or articles and which are not themselves manufactured, registration/notification obligations of the substance
imported or placed on the market, are exempt from in the article remains with the initial article producer/
registration (Annex V n°4 REACH). Further exemptions importer in the absence of transfer of ownership. REACH
to register substances resulting from a chemical compliance for the treatment activities, however, has to
reaction which may be of relevance to downstream be ensured by the subcontractor.
users, are listed in Annex V REACH.
36 5.2 REACH Scope and Exemptions
5.2
Exemptions
Product and process oriented research and
REACH applies without prejudice to: development (PPORD):
• Community workplace legislation including Substances manufactured or imported for the purposes
Directives 89/391/EEC, 98/24/EC and 2004/37/EC of product and process oriented research and develop-
• Community environment legislation including ment (PPORD) by a manufacturer or importer or
Directives 96/61/EC and 2000/60/EC producer of articles are exempted from Articles 5, 6,
7, 17, 18 and 21 of Title II REACH (registration) for a
There are a number of exemptions from certain period of five years. ECHA may prolong the five years
Titles of REACH, generally defined according to the to ten years for certain substances and uses. The
following criteria: manufacturer, importer or producer of articles shall in
this case notify certain information to ECHA (Article 9
AIG on REACH 3.1
Tonnage: REACH).
Substances on their own, in mixtures or in articles
(where there is an intended release under normal On-site isolated intermediates and transported
or reasonably foreseeable conditions of use) isolated intermediates:
manufactured or imported below 1 tonne per On-site isolated intermediates and transported
manufacturer/importer per year are exempted from isolated intermediates are exempted from Chapter 1
registration (Title II REACH). of Title II REACH (registration) with the exception of
Articles 8 and 9 REACH. They are also exempted from
N.B. The tonnage limit does not apply to authorisation, authorisation (Article 2.8 REACH). However, specific
restriction, classification and labelling or safety data registration obligations and information requirements
sheet requirements. for certain types of isolated intermediates are described
in Chapter 3 of Title II REACH.
37
Polymers: NOTE
Polymers are exempted from registration and The scope of REACH will be reviewed in 2012
evaluation but may still be subject to authorisation and
restrictions.
However, manufacturers or importers of a polymer For exemptions from authorisation, please refer to
must submit a registration to ECHA for the monomer Chapter 5.10
substances or any other substances that have not
already been registered by an actor up the supply chain For more details, please refer to
under certain conditions (Article 6.3 REACH). Articles 1, 2, 6, 9, 138.4, 138.6 REACH
www.acea.be/reach
38 5.3 Substance Inventory
5.3
A key step for downstream users to comply with • Which substances are intended to be released
the REACH and CLP Regulation is to have a full from an article that the company produces in the
understanding of what substances/mixtures the EEA?
company uses or imports either on their own or in an If you produce articles in the EEA, intentionally re-
article. Establishing a substance inventory will allow leasing substances, without this substance having
the company to determine: been pre-registered/registered by an actor up the
supply chain, you will be obliged to register the sub-
• Which substances/mixtures the company pur- stances released under certain conditions (see Chap-
chases from a European supplier and for what ter 5.7).
purpose they are used?
You may contact the chemicals supplier to ensure • Which substances are intended to be released
that the substance/mixture will continue to be sup- from an article that the company imports?
plied and that the company’s use will be covered in If no OR of a non-Community manufacturer has been
the substance registration dossier, in the Chemical appointed, you are obliged to do late pre-registration
Safety Report and in an exposure scenario (see Chap- or registration of the substances intentionally re-
ter 5.5).” leased from the article that you import.
An efficient way of data collection is to request sup-
pliers to deliver SDS/eSDS (or an SDS-like document) • Which imported substances/mixtures are dan-
for all substances and mixtures, independent of gerous according to
whether they are hazardous or not. •• Article 57 REACH (SVHCs)
•• Article 67 REACH (Restriction)
• Which substances/mixtures the company im- •• CLP Regulation
ports from outside Europe? •• Regulation (EC) No 552/2009 amending REACH in
Unless an “OR of a non-Community manufacturer, regard to Annex XVII
who will take over the obligations as an importer, Identify substances in the substance inventory which are
has been appointed, you will have to comply with classified as hazardous under CLP and which are present
REACH obligations as an importer. This may result in a mixture above the concentration limits specified in
in the obligation to go through registration of those Annex I of CLP or as specified in Annex XVII of REACH.
substance/substances in mixtures. These cases may
not be obvious: for example, if you import a lubricant • Which articles contain Dangerous Substances?
from a non-EEA supplier in order to supply it to your You need to know this information to be able to fulfil
customer (either with equipment or as part of a ser- your REACH obligations on Notification (Article 7.2
vice contract), you may be obliged to generate the REACH: See Chapter 5.9), Communication (Article 33
data package for registration in order to be allowed REACH: See Chapter 5.10), Authorisation (Article 56
to continue to supply that substance/mixture REACH, Annex XIV: See Chapter 5.11) and Restriction
(see Chapter 5.4). “ (Article 67 REACH, Annex XVII: See Chapter 5.12)
AIG on REACH 3.1
• For which substances/mixtures the company • Depending on your role under REACH, you need
purchases, SDS/eSDS are available/not available? to collect the following key information in order
For hazardous substances/mixtures that are fulfill- to determine your REACH obligations (if any):
ing certain criteria, the supplier has to provide SDS/ •• Substance/mixture name
eSDS. If you have received such SDS/eSDS, you may (supplier’s proprietary name, if any)
have to fulfil several obligations to be REACH compli- •• Chemical name
ant. This may have an impact on both your produc- •• CAS number (if any)
tion process and your products. (see Chapter 5.5) •• EC number (if any)
•• REACH registration number if available (starting
with “01” for registered substances or “05” for pre-
registered substances)
39
•• INDEX number or CLP Reference number for dan- •• Will the substance/mixture continue to be avail-
gerous substances (also < 1 tpa) according to Ar- able for purchase?
ticle 18 CLP (product identifier) •• Is the substance on the CL, on Annex XIV (Authori-
•• Amount of substances imported into or used in the sation List) or on Annex XVII (Restriction List)?
EEA per year (kg) •• Can the substance be substituted (if it is likely to be
•• Supplier name and address (responsible individual withdrawn in future)?
for each supplier) •• If you need to produce a data package for registra-
•• Is it imported by you? tion and/or notification to the CLP Inventory, what
•• Is the substance identified as of very high concern? data is necessary?
If yes, is it already on the CL or does it already have •• Who else supplies the substance or mixture?
an authorisation number?
•• Is the substance critical for your business? Additional considerations:
Please note that the level of detail of the information to
• Possible further information you may add to your be collected may vary, depending on the different roles
substance inventory is: that a company may play. The matrix below gives an
•• Have you contacted the supplier about registration overview of these roles and the necessary information
for your use? for each.
•• Is there a confidentiality issue regarding specific
uses? Recommended data for inventories, depending on the
•• Is the substance already pre-registered/regis- different roles:
tered?
releasing substances
(incl. Substance information)
Imported articles, intentionally
releasing substances x x
(incl. Substance information)
Taking into consideration this simple example, the Especially for inventories related to articles,
company would have the following roles under the automotive industry in general has already
REACH13: established several tools to be compliant with
other obligations (ELV, RRR, etc.). It is of course
• Article producer in the EEA recommended to use those tools (see Chapters 5.8
(In their own plant) and 5.9).
• Article importer into the EEA
(From their plant outside the EEA)
• Downstream user of mixtures
(From an EEA supplier)
• Importer of mixtures into the EEA
(Only in case that supplier has no Only
Representative in the EEA)
• Downstream user of substances
(From an EEA supplier)
• Importer of substances into the EEA
Within REACH, the role of a “Downstream User of Articles”
13
(Only in case that supplier has no Only does not exist; rather “Recipient of Articles” is the appli-
Representative in the EEA) cable term.
AIG on REACH 3.1
5.4 Imports of Substances /Mixtures /Articles
41
Import under REACH means “the physical introduction • Import a substance (included in Annex XIV) on its
into the customs territory of the Community” (Article 3.10 own (authorisation obligation according to Article
REACH). The importer is further defined as any natural 56 REACH). See Chapter 5.10
or legal person established within the Community who
is responsible for the import” (Article 3.11 REACH). • Import articles with CL substances included above
Substances on their own, in mixtures and in articles 0.1% w/w, to be supplied to the next recipient in the
which, are imported from outside the EEA underlay EEA (communication according to Article 33 REACH).
different obligations under REACH (Registration, See Chapter 5.9.
Notification, Communication, Authorisation), following
the same rules as if manufactured/supplied in the EEA. • Import articles with CL Substances included above
e.g. registration is required for substances intended 0.1% w/w and exceeding 1 tonne per year per
to be released from an imported article, following the importer (notification requirement according to
same regime as substances intended to be released Article 7 REACH). See Chapter 5.8
from an article produced in the EEA (see Chapter 5.7).
REACH procedures for an imported substance on its • Import an article intentionally releasing a substance
own, in mixtures or in articles may be carried out by: and the substance is present in articles in quantities
of 1 tonne or above per year per importer (registra-
The “OR of a non-Community manufacturer”: tion obligation according to Article 7.1 REACH). See
Article 8.1 REACH foresees that a natural or legal also Chapter 5.7
person established outside the Community who
manufactures a substance on its own, in mixtures or • Provide SDS/eSDS of imported substances or mix-
in articles, formulates a mixture or produces an article tures to their next recipient. The initial responsibility
that is imported into the Community may by mutual for drawing up the safety data sheet falls to the man-
agreement appoint a natural or legal person established ufacturer or importer, who should anticipate, so far
in the Community as an OR to fulfil all the obligations as it is reasonably practicable, the uses to which the
of the importer. substance or preparation may be put. Actors further
down the supply chain should also provide a safety
If an OR is appointed, the EEA importers of the same data sheet, drawing on, checking the adequacy of and
supply chain, whether they are affiliated to the non-EEA adding to, the information provided by their suppli-
supplying company or not, are regarded as a DU and do ers to cater for the specific needs of their customers.
not need to carry out the affected REACH requirements. In all cases, suppliers of a substance or a mixture
The OR of the non-community manufacturer has which requires a SDS/eSDS have the responsibility
the legal responsibility to comply with all relevant for its contents, even though they may not have pre-
obligations under REACH and must be based in the EEA pared the SDS/eSDS themselves. See Chapter 5.5.2
(Article 8.2 REACH).
When an OR submits a registration, a copy of the letter OR, update the registration dossier by changing the
of the non-EEA manufacturer(s) officially assigning registrant identity, and if necessary, any other issues
the OR is also required. For phase-in substances, the (e.g. change of tonnage band) (Article 8 REACH).
OR must also pre-register the substance and will
subsequently become a participant of the Substance It is possible that an OR is named for all legally
Information Exchange Forum (SIEF). incorporated or registered entities of an importing
company. In such cases, the legal entity taking over
Moreover, an OR will have to keep all up-to-date the role of an OR will carry out the pre-registration/
available information on quantities imported, the list registration for all other parts of the organisation. They
of EEA customers of the exporters he represents, as will then assume the status of DU under REACH.
well as information on the supply of the latest update
of the SDS/eSDS. The non-EEA manufacturer must
inform all EEA importers in the same supply chain NOTE
that a representative in the EEA has been appointed as The OR obligations are not limited to registration
an OR, who then becomes legally responsible for the duties only but include all other obligations
registration. Nevertheless, it can be anticipated that of manufacturers/importers (e.g. notification
in most cases, it will be the non-EEA exporter that will (Article 7.2 REACH), communication (Article 33
provide the OR with all necessary data for the dossier. If REACH, authorisation (Article 56 REACH), SDS
a non-EEA manufacturer decides to change his OR, the obligations (Article 31 REACH), etc)
newly appointed OR can, in agreement with the former
www.acea.be/reach
44 5.5 Downstream User Obligations
according to REACH, Title V
5.5
In REACH Title V (Article 37 to 39) the DU has the per manufacturer/importer. For hazardous substances
right to make his use known to his suppliers. The between 1-10 tpa the use is communicated via a normal
supplier has the duty to evaluate the use and to provide SDS where only general use categories are included.
information back to the DU on whether or not the use
can be supported as an identified use. If the use is not
supported, the DU has several options to continue using Note
the substance. Certain deadlines have to be respected There are two different ways to communicate
for the communications between DU and supplier. In identified uses under REACH:
addition, there are also obligations for DUs to report »» For hazardous substances between 1-10 tpa: SDS
information to ECHA under special conditions. including general use categories (only reduced
information)
The ECHA guidance for DUs provides assistance with »» For hazardous substances >10 tpa: eSDS includ-
all tasks. Table 5 of the guidance document (ECHA ing Use Descriptors (detailed information)
2008, chapter 2.5.5, P. 25) provides an overview in
regard to possible obligations related to different roles.
In Chapters 3 and 4 of the ECHA guidance for DUs, Non-hazardous substances or mixtures without
recommendations are given on how a DU can prepare hazardous ingredients do not require a SDS and
for REACH and what is to be done when a DU receives therefore have no use restrictions. In this case an ES is
new information. not provided to DU.
NOTE
5.5.2 Upstream Communication of
All obligations under Title V of REACH are limited
Uses
to substances or substances in mixtures which
are hazardous according to CLP. Refer to Title V of If a DU identifies a new hazard of a substance or a
REACH for more information. substance in a mixture, the supplier has to be informed
in order to enable the appropriate risk assessment
to be performed. The purpose is to cover the hazards
in an update of his registration dossier and to
communicate down the supply chain the appropriate
5.5.1 Downstream Communication
Risk Management Measures (RMM).
of the Uses
In order to secure a continued supply of a hazardous
substance on its own or in a mixture a DU has to check Note
whether the supplier will support their use(s) by DUs are obliged to understand the REACH
including them in the substance registration dossier. communication tools (e.g. SDS/eSDS, use
descriptors, exposure scenarios etc.). Thus, it is
AIG on REACH 3.1
Any use of a substance by a DU outside the supported highly recommended that DUs learn how to read
uses is not allowed. If DUs are not sure if their the information in the SDS / eSDS including the use
supplier is aware of their use, it is in the interest of descriptors.
DUs to communicate early with suppliers with the In order to be able to compare the suppliers’
view of having their use(s) included in the supplier’s exposure scenarios, DUs should prepare their
registration dossier. own ESs for their use conditions, using the Use
Descriptors as described in the ECHA Guidelines.
For hazardous substances >10 tpa, the supported uses
are communicated through the ES in the eSDS. Such
eSDS will be issued once the registrant has made his DUs may assist in the preparation of a registration.
registration. The registration deadline depends on the They have the right to make known in writing
hazard classification of the substance and its volume (on paper or electronically) their use(s) to the supplier
45
so that they become an identified use. A DU can also which need only to be checked for completeness
provide a system of brief general descriptions of uses i.e. that your identified uses are covered.
that can be used as a minimum to identify such uses Suppliers of substances or substances in mixtures
to the supplier. In making the use(s) known, DUs shall are urged to contact the appropriate association
provide sufficient information to allow the supplier for the substance in question, to make sure that
to prepare an exposure scenario/use and exposure their use becomes an identified use in the generic
category that can be included in the chemical safety exposure scenario. (For further details see Annex
assessment (Article 37(2) REACH) if necessary. L3 “Automotive Industry Recommendation on
Exposure Scenarios”)
The deadline for this feedback communication is
1 year before registration has to be carried out by the
manufacturer. Other deadlines are as follows; To protect intellectual property rights it is
• 31 May 2012: deadline for communication of the recommended that the DU explains the use in general
identified uses to the upstream user of substances terms. Nevertheless in special cases it may be useful to
which have to be registered by 1 June 2013. communicate in detail with the supplier to make sure
• 31 May 2017: deadline for communication of the that all conditions of use and/or risk management
identified uses to the upstream user of substances measures are covered by the exposure scenario.
which have to be registered by 1 June 2018.
DU should therefore:
Therefore it is strongly advised that DUs start • As a first step, identify the substances and substances
communicating as early as possible with their suppliers. in mixtures used in their industrial processes (see
Chapter 5.3).
If a DU makes a formal request in writing to a supplier to • As a second step, if the supplier intends to carry out
have the use(s) of a substance included and the supplier, registration procedures, ask whether the supplier
after having assessed the use in accordance with Article has already established use and exposure scenarios
14 REACH, is unable to include it as an identified use covering their use(s).
(for reasons of protection of human health or the • DU may also check SDS/eSDS provided to them to
environment), the supplier must without delay provide see whether their uses and all conditions of use/
the ECHA and the downstream user with the reason(s) RMMs are already covered (see next Chapters 5.6.1
for that decision in writing. (Article 37.3 REACH). and 5.6.2). If the supplier has not elaborated a use
and exposure scenario, a DU may take a pro-active
For suppliers or distributors with only a small number role and provide their supplier with information to
of customers, it is possible to communicate by letter. develop an exposure scenario/use in order to ensure
However, most suppliers (and distributors) within the that their uses will be covered.
automotive industry have significantly more complex
supply chains with a large number of customers of
different sizes. For these companies, there is a great NOTE
deal of concern that using letters could result in an The use of a substance on its own or in a mixture
unmanageable administrative burden. The use of by DUs within the automotive industry should be
www.acea.be/reach
Company (Supplier)
REACH-Responsible
REACH-Responsible Business Unit 3
Business Unit 2
REACH-Responsible
REACH-Responsible Business Unit n
Company internal communications
Business Unit 1
REACH-
Representative
Communication
between
companies
REACH-
Representative
REACH-Responsible
Business Unit 2 REACH-Responsible
Business Unit 3
Company (Customer)
SDSs have been a well-accepted and effective method In addition, according to Article 31.7 REACH, registrants
for the provision of information to DUs in regard and users that had to prepare a CSR shall place the
to chemical substances and mixtures in the EEA. relevant exposure scenario(s) into an Annex of the SDS
They have been made an integral part of the system of which then becomes an eSDS. A DU has to take into
REACH. consideration relevant exposure information received
from suppliers when compiling his eSDS.
The SDS provides a mechanism for transmitting
appropriate safety information on substances and The SDS is intended for professional DU in order
mixtures which meet the criteria for classification to provide the information necessary to use the
as hazardous, persistent, bioaccumulative and toxic substance or mixture safely. It is an essential document
or very persistent and very bioaccumulative or are for providing data with particular relevance to the
included in the CL for authorisation for any other reason protection of human health and the environment.
and under certain conditions some mixtures which do
not meet the criteria for classification as hazardous Any updated information on authorisation, restriction
(Article 31.3 REACH). or risk management measures must be made available
by the supplier to all former recipients to whom they
have supplied the substance or mixture within the
NOTE 12 preceding months. It should be made available free of
According to Art. 31, REACH, a SDS is not required charge, on paper or preferably electronically. Any updates
for articles. However according to Art. 13 of following registration shall include the registration
the Pyrotechnic Directive 2007/23/EC, a SDS is number. However, the existence of a registration number
currently required for pyrotechnic articles as used does not trigger an update of the SDS.
in vehicles and supplied to professional users.
However, the Directive 2007/23/EC is currently Also for non-hazardous substances communication
under revision. duties have to be fulfilled (Article 32 REACH). Here the
supplier has to provide information on:
The SDS/eSDS includes information from the • Whether the substance is subject to authorisation
relevant Chemical Safety Report (CSR) if one exists. and details (e.g. authorisation number, special provi-
The information provided in the SDS/eSDS shall be sions) of any authorisation granted or denied in this
consistent with the information in the CSR as well as supply chain.
with the registration dossier. Usually a SDS/eSDS is • Details of any restriction.
created by using pre-defined phrases. • Any other available and relevant information about
the substance that is necessary to enable appropri-
ate risk management measures to be identified and
NOTE applied. In case information has to be given for one of
An example of a source of standard phrases is the the above reasons, the registration number has to be
European Phrase Catalogue (EUPhraC), which is provided if available
available free of charge in German and English. This
www.acea.be/reach
catalogue contains phrases in a well-structured In general there is a difference between the information
form which have been shown to be useful in SDSs. the registrant (i.e. manufacturer or importer) has
The catalogue is being updated continuously and is to provide to ECHA and the information he has to
available at: www.euphrac.eu communicate along the supply chain (with or without
SDS) to the DU.
The following picture provides an overview of the
registration and communication requirements for a
substance along the supply chain. A more detailed
overview is provided in Annex K:
48
5.6
REACH
no CSR15 and
> 10 tpa
REACH
Art. 31
< 1 tpa
Picture 5.6.1 overview about the registration and communication requirements for a substance
14
CSR contains in addition exposure scenario(s) and an exposure/risk assessment.
The exposure scenario(s) have to be delivered to the next supply chain member as SDS attachments.
15
Information according to Article 10 REACH and in addition according to Annex VI (6) i.e. exposure related information
(use and exposure categories).
16
SDS is required for PBT/vPvB substances or endocrine disruptors which do not meet the criteria of CLP. If no SDS is required,
information according to Article 32 REACH (without format proposal) might have to be communicated along the supply chain.
or mixture is placed on the market. Only when the is different to that of the supplier.
Member State(s) concerned provide(s) otherwise
(Article 31.5 REACH) can the SDS be in another lan- • Consistency between information given in sections 9,
guage17. It should be noted that it is for the recipient 11 and 12 and the classification.
Member State to provide otherwise.
• Whether an exposure scenario (ES) is attached to the • Appropriateness of the RMM: according to Article 34
eSDS and whether it corresponds to the DUs use of REACH, the DU needs to report back to the supplier if
the product. they are inappropriate.
• Whether the information mentioned in the SDS/eSDS
is sufficient for workplace and environmental risk • Any other available and relevant information about
assessment. the substance that is necessary to enable appropriate
RMMs to be identified and applied.
49
NOTE
DUs should be aware that REACH & CLP are providing transitional periods for SDS until 2017. Within these
periods, DUs may receive different formats of SDS.
31.12.2008
CLP 4½ years
Substances Mixtures
DSD = Dangerous Substance Directive 67/548/EEC | DPD = Dangerous Preparation Directive 1999/45/EC
Picture 5.6.1.1 Transition periods according to REACH & CLP
In most cases DUs will receive the following outside the conditions described in the exposure
kind of SDS (Article 31 REACH): scenario, or if the uses are not covered, or for any
use(s) the registrant advises against, he has several
1. For all hazardous substances above 10 tpa (for options:
example technical gases like ammonia or solvents •• DU may make the use/use conditions known to his
like isopropanol) the DU will receive an eSDS for the supplier so that the supplier can prepare an expo-
substance. eSDS mainly differ from “normal” SDS by sure scenario covering them.
www.acea.be/reach
having exposure scenario(s) attached as an annex, •• DU may change the conditions of use or modify the
relevant identified uses in section 1 and DNEL/PNEC variable scaling parameters within the ES (scaling)
values in section 8. so that they are covered by the supplier’s exposure
Related DU obligations: scenario.
If a DU receives an eSDS, he has to check whether the •• DU may find another supplier who provides an
current use is covered and whether his workplace exposure scenario covering the particular use(s)
and environmental risk assessment and the RMM are and conditions of use(s).
covered by the attached exposure scenario as well as •• A CSR may be prepared by the DU according to
the operational conditions described therein.
If a DU uses substances (e.g. formulating a mixture) 17
Source: Draft Guidance on the compilation of safety data sheets
50
5.6
Article 37.4 REACH and notification made to ECHA scribed in the ES/use by modifying his production
for the additional use(s) as described in Article process
38.1 REACH. •• DU may find an alternative substance or process
•• DU may implement the conditions of use as de- if possible and discontinue using the substance in
question (substitution).
ES
e-SDS
Downstream User
Source: REACH Practical Guide on Exposure Assessment and Communication in the Supply Chains Part II: Exposure Scenarios and
Communication in the Supply Chains, Figure 5, modified by automotive industry. “Further actions” are options which can be chosen
by the downstream user as alternatives or in parallel.
An exposure scenario generally describes how eSDS but the conditions of use and risk management
a substance can be safely used under the given measures are different from those in your own pro-
operational conditions of use and which risk cesses, because they are mainly estimated by using
management measures (RMM) should be ap- worst case ES estimation tools (e.g. ECETOC-TRA18).
plied to control risk to humans or the environ- In those cases the obligations according to REACH
ment. Exposure scenarios must be compiled Title V have to be considered.
by the registrant, as part of the registration
dossier, for certain substances on their own
or in mixtures, which are imported/manufac-
tured in quantities over 10 tpa and hazardous
according to CLP.
18
http://www.ecetoc.org/tra
51
2. For mixtures containing hazardous substances place exposure limit value or environmental rel-
≥10 tpa (e.g. coatings), two kinds of SDS are legally evant threshold or technical equipment approval
possible (2a or 2b below). A third option was devel- conditions are yet available.
oped by the chemical industry (2c):
a) A “normal” SDS for the mixture without any ES at- NOTE
tachment and where all RMMs for safe handling Exposure scenario(s) for mixtures do not ex-
are included in the main body. For general infor- ist, because mixtures are not subject of regis-
mation around SDS: see also Chapter 5.6.2 of this tration and no safety report is legally required
guideline. for them (see attachment: position paper
of the EU commission dated 28. April 2006.
NOTE Quote: “Finally, the Council has in its Common
This is the recommended option for commu- Position decided to delete Annex Ib (Chemical
nication of SDS for mixtures. Even if no ES is Safety Assessments for Preparations) given
contained in the SDS as an annex, the DU must that the scientific methodology underpinning
still consider the specifications given in sec- this Annex is still being developed”). Special
tions 1-16 of the SDS. substances may be regarded as mixtures under
CLP and REACH (multi-consistent substances
and/or complex substances, alloys etc.). For
b) A SDS for the mixture where all relevant ES of these “substances” a CSR may be reasonable.
the registered hazardous substances ≥10 tpa are
attached (“SDS book”).
If the DU receives such a SDS it has the obligation
Further DU information obligations around
to check substance-wise all attached ES to see
SDS, ES and Article 32 REACH
whether the uses and the conditions of use (OC)
are covered (REACH compliance check). The DU must compare the RMM in a risk assessment
with the recommended risk management measures,
NOTE as indicated in the SDS communicated or supplied in
Automotive industry recommendation that accordance with Article 32 REACH. Any differences can
even if option 2b is legally correct to ask your lead to further obligations.
supplier to submit a consolidated SDS describ-
ing the risk of the whole mixture in the main According to Article 34 REACH any actor in the supply
body of the SDS (see point 2a) instead of pro- chain of a substance or a mixture also has the obligation
viding a “SDS book” in order to avoid unneces- to communicate to the next actor up the supply chain,
sary administrative work. if:
• New information on hazardous properties is dis-
covered, regardless of the use.
c) A SDS with a “consolidated exposure scenario for • Any other information is discovered that might call
the mixture”, developed by the chemical industry. into question the appropriateness of the RMM identi-
fied in the SDS supplied, and this shall be communi-
www.acea.be/reach
Because the DU duties of REACH Title V are related cated for identified uses (Article 34 REACH).
to substances and substances in mixtures only but
not to the mixture itself, the duties resulting from Workers shall be granted access by their employers to
a “consolidated exposure scenario for mixtures” the information provided in the SDS and in accordance
are not equivalent to those resulting from an ex- with Article 32 REACH on substances or mixtures
posure scenario for substances. DUs may consider that they use or may be exposed to during their work
the information obtained from such a consolidat- (Article 35 REACH).
ed exposure scenario for a mixture for their own
workplace and environmental risk assessment,
especially in those cases where no national work-
52
5.6
Note Note
As there is no legal obligation, you would have to The TF REACH members have agreed upon the use
put additional requirements into your supplier of a common open IT-standard for exchanging a
contracts/purchasing conditions. SDS. The automotive industry therefore supports
the concept and further development of the EDAS
standard and recommends their suppliers to
Option 3 implement an EDAS interface in their IT systems to
Collect SDS for all substances & mixtures where simplify communication up and down the supply
legally required plus SDS-like information also for chain. (See Annex L6 “Position paper EDAS Final”)
those where no SDS is legally required.
In the case of substances and mixtures where no SDS is
legally required ask your supplier for safety information,
having the same content and format as the SDS but
5.6.4 Update of SDS
without naming it SDS.
Advantages: The conditions under which a SDS must be updated and
• You fulfil the legal requirements and remain in the re-issued are given in Article 31.9 REACH as follows:
existing IT systems.
• See advantages of option 2 above. Suppliers shall update the SDS without delay on the
• None of the above disadvantages apply following occasions:
a) as soon as new information which may affect the risk
management measures, or new information on haz-
Note ards becomes available;
»» It is the recommendation of TF REACH to use b) once an authorisation has been granted or refused;
Option 3 in order to collect all necessary infor- c) once a restriction has been imposed;
mation on the registration of substances on their In addition it is also recommended to update SDS once a
own or in mixtures. substance has been added to the CL for authorisation.
»» As there is no legal obligation, you would have to
put additional requirements into your supplier The new, dated version of the SDS, identified by
contracts/purchasing conditions. ‘Revision: (date)’, shall be provided free of charge on
paper or electronically to all former recipients to whom
they have supplied the substance or mixture within the
preceding 12 months.
recommendation. This will be published separately Although there are industry recommendations available
in a TF REACH communication paper. The objective on when a change in a SDS is considered a “major” or
is to have a common communication tool as open IT- a “minor” change, this terminology is not used in the
standard which is combined with the EDAS Exchange REACH Regulation. Only the above mentioned changes
Format for SDS. (a to c) give rise to a legal obligation to provide updated
versions to all recipients to whom the substance
or mixture has been supplied within the preceding
12 months.
54 5.7 CLP Notification
5.7
• > 1tpa and thus subject to Registration under REACH • the substance does not meet the criteria of CLP and is
irrespective of whether or not the substance is imported < 1 tpa.
hazardous (CLP).
NOTE
• present in a mixture above the concentration limits »» Certain substances that are exempted from
specified in Annex I of CLP or as specified in Directive registration under REACH may well be sub-
1999/45/EC, where relevant, which results in the ject to C&L notification. This includes, for ex-
classification of the mixture as hazardous, and where ample, active substances in biocides and plant
the mixture is placed on the market. protection products, polymers (if hazardous,
see Article 6.3 REACH), and small tonnages
• contained in articles where Article 7 REACH provides (< 1 tpa) of hazardous substances.
for their registration (check Chapter 5.8 for examples »» Article 39(b) CLP refers to all hazards. This
AIG on REACH 3.1
Timeline:
• General rule: Within one month from placing on the
market
• Substances on the market on 1 December 2010 had
to be notified by 3 January 2011
www.acea.be/reach
56 5.8 Registration of Substances in Articles
5.8
Examples
The kit is not part of the vehicle. Thus, there are
The global automotive industry has identified the no registration obligations acc. to Art 7.1, REACH.
following list of examples of articles that inten- However, if you are importing it (even if in an imported
tionally release substances after being assembled vehicle) you are considered as an importer of a
onto a vehicle, when normal use conditions apply: substance/mixture.
1. Fragrance dispensers, In such cases one should check the amount of imported
2. Fire extinguisher systems substances in the sealant mixture. If the 1 tpa threshold
(excluding a hand held mobile fire extinguisher). is exceeded, either the OR or the company concerned
3. Windshield-washer fluid reservoirs, will need to undertake a registration under Article 6
4. Pyrotechnic devices that release compressed gases. REACH, unless already done so by the upstream
Please note that although a pyrotechnic device with supplier. Alternatively, supply can be changed to an EU
compressed gas is considered as an article with sub- supplier so that you are not anymore an importer.
stances that intentionally release when activated in
a vehicle, basic elemental substances for which haz- As a general rule, the term ‘intended to be released’
AIG on REACH 3.1
ards and risks are already well known (hydrogen, implies that a certain (accessory) function or quality of
oxygen, noble gases, nitrogen) are exempt from reg- an article is connected to the release of a substance or
istration, per Annex V (9) of the REACH regulation. mixture.
Registration may be required if other substances or
mixtures are utilised. A release of substances is not considered to be an
intended release if it is an unavoidable side effect of
the functioning of the article, but the release does not
contribute to the functioning of the article. Examples:
wear and tear of materials under conditions of high
friction, e.g. break linings, tyres; leakage of lubricant
used to reduce the friction between two moving parts
(see Guidance on requirements for substances in
57
5.9
Both producers of articles in the EEA and importers on the CL due to the tonnage not being tripped,
(or OR) of articles from outside the EEA must notify the situation should be monitored as the ton-
ECHA if the substance present in articles meets all of the nage threshold may be exceeded in subsequent
following conditions in line with Article 7.2 REACH: calendar years when production/import of ar-
ticles containing the substance increases.
• The substance has been added to the CL for autho-
risation Example
• The substance present in articles is above a concen- A substance is added to the CL on 1.6.2012. The
tration of 0.1% w/w company importing or producing articles con-
• The substance is present in those articles where the taining this substance will have to start investi-
concentration exceeds 0.1% w/w in quantities total- gating and calculating from that point in time till
ling over 1 tpa (per producer/importer) the end of that year and not from the beginning
of 2012. The tonnage of the substance is con-
Note sidered to be zero on 1.6.2012 and again on the
The definition of “per year” in the legal text (Art. 1st of January of 2013. The tonnage calculation
3.30) which is copied into the definition sec- needs to be done for each calendar year that you
tion of the AIG does not explicitly state that it produce /import articles following the inclusion
applies to substances on their own, in mixtures of the substance on the CL, but only if there is
or in articles as other parts of the legal text do. an increase in production/import volumes (of
Furthermore, Art.3.30 states “ unless stated oth- articles containing the substance) after the first
erwise, for phase in substances that have been tonnage calculation.. A notification is only re-
imported or manufactured for at least three quired once.
consecutive years, quantities per year shall be
calculated on the average production or import
volumes for the three preceding calendar years.” Notification is not required:
and therefore applies to substances imported/ If the substance has already been registered for that use
manufactured as such and has nothing to do by a member of any supply chain (Article 7.6 REACH)
with notification of CL substances in articles. TF
REACH is of the opinion that this provision was The registration needs not to be done by an actor
put in place to avoid situations where a sudden of your supply chain but can be made by any other
increase in demand would lead to legal entities manufacturer or importer of the CL substance. For
being unable to comply with the registration ob- articles produced in or imported into the EEA it is
ligations. necessary to check if the use of the substance in the
Having given due consideration to the term “per article is supported by the registration so as to avoid
year” and whether it should apply to notifica- the notification obligation.
tion, we reached the conclusion that in the case
of notification the “per year” starts from when A substance is considered to have already been
AIG on REACH 3.1
the substance is included in the CL for authori- registered for a particular use, if two conditions are
sation. In case the 1tpa threshold is not reached fulfilled:
during the remainder of the year when the sub- • The substance in question is the same as a substance
stance appeared on the CL for authorisation, that has already been registered.
the calculation should start again on the 1st of • The use in question is the same as one of the uses
January of the following year. The reason behind described in a registration of this substance that was
this decision is that companies will not have ac- already made.
cumulated information about a CL substance
being present in an article before the substance The first step in the process is to ensure that the
appears on the CL. substance in question is the same as a substance that
Should a notification not be necessary during the has already been registered Comparing names and
year following the introduction of the substance EINECS or CAS numbers of both substances may not
59
always be sufficient. When deciding whether or not two recommended to use other information sources on
substances can be regarded as the same, the “criteria registered uses by contacting appropriate bodies, such
for checking if substances are the same” given in as SIEFs, lead registrants, substance consortia and
chapter 5 of the Guidance for identification and naming substance-responsible associations. Efforts to make
of substances under REACH should be applied. contact with these bodies can in practice prove to be
difficult as business confidentiality considerations
A potential notifier of a substance in articles must may thwart the disclosure of the required information.
check if the use of the substance in his articles is the It is recommended that any such correspondence is
same as one of the uses described in a registration of recorded.
this substance that was already made. For this he has
to describe the function of the substance in the article. If you have an inventory for the articles that you
Normally the function of a substance would include a produce or import, you may have information about
verb e.g. ‘soften’ (in the case of a phthalate (plasticiser)) the materials and the produced/imported volumes.
but as the registration dossiers and the dissemination This information will provide you with a first indication
data do not include this, it is necessary to draw a on whether a notification may be required once a
conclusion from the noun e.g. plasticiser. The process substance is included in the CL (see chapter 5.3).
by which the substance is included in the articles and
into which type of article should also be described.
Example on how to check that your use of a
Comparing your use with a description of use only based CL substance is covered by an already made
on the use descriptor system will not be sufficient to registration using the example of DEHP in electric
conclude on the sameness of two uses for the purpose wires and cable:
of establishing whether an exemption on the basis of 1. Check whether DEHP has already been registered.
Article 7(6) applies. Thus, the “Article Category” (which a) Go to the ECHA website by following the link:
is generally a very broad description often referring http://apps.echa.europa.eu/registered/regis-
only to the material) will not be detailed enough (see tered-sub.aspx
Chapter 6.4 of the Guidance on substances in articles). b) Check registration status for DEHP by entering the
Therefore, the use in question has to be described CAS number 117-81-7;
more in detail than just by using elements of the use RESULT: full registration dossier data available
descriptor system.
2. Check that the substance in question is the same as
The published information that a substance has been the substance that has already been registered.
registered for use in the Article Category ‘Plastic articles’
does not necessarily mean the registration is made to Note
cover all plastic articles. It could mean that use of the For DUs in the automotive industry, the Article
substance in production of some specific plastic articles Category (AC) has to be considered while check-
is covered and described in the registration, while other ing the registration of uses. The ACs are describ-
plastic articles are not covered and assessed. The uses ing the type of article in which the substance is
of two very different plastic articles may lead to very known to be included on its end use.
www.acea.be/reach
3. Check if the type of article is covered in the regis- If your exposure release category is the same then
tration dossier. In this example you must check for you are covered by the already made registration of
‘electric wires and cable’, covering also its synonyms, the substance.
e.g. wiring loom, wiring harness, cable assembly,
wiring assembly, etc.. This information is not available 7. Cross-check whether there are no restrictions on
on the registered substance list disseminated on the use(s) of DEHP in the article for your use:
ECHA website and must be obtained by other means a) Click on details and go to chapter “Manufacture,
e.g. from the lead registrant, consortium, association, Use & Exposure” and check whether no uses ad-
internet etc. After receiving requested information vised against your scope of use are listed.
from above mentioned additional sources, check for b) No restriction(s) listed -> OK!
“electric wires and cable”. If this covers your Article
Category you are covered by the already made Note
registration. Should you find your use is not covered by an al-
ready made registration you are recommended
4. Check the sector of use of electric wires and to take necessary action making sure your use
cable. The registration dossier for DEHP specifies is covered. Please refer to chapter 5.5 “Down-
“Consumer uses: Private households (=general public stream User Obligations according to REACH,
= consumers)”.. If this covers your Sector of Use you Title V” for options.
are covered by the already made registration.
5. Check the product category in the registration 8. Conclusion: If you consider that the example above
dossier. For electric wires and cable the product covers your uses of DEHP in electric wires and cable,
category is “Polymer preparations and compounds”. no notification is necessary. The conclusion obtained
If this covers your product category you are covered and the considerations that led to it should be well
by the already made registration. documented in order to be able to demonstrate
REACH compliance towards authorities when
6. Check the exposure release category (ERC) included required.
in the registration dossier. In the case of the articles
electric wires and cables the exposure categories Note
are: »» Incorporation of a substance in an article is a
“use”. However, the placing on the market of
Low release of substances included into or onto arti- an article is not a use.
cles and materials during their service life in outdoor »» If you are not certain that your specific use is
use, such as metal, wooden and plastic construction already registered you should notify.
and building materials (gutters, drains, frames, etc.)
(ERC10a)
Please refer to the factsheet on notification for
AIG on REACH 3.1
Substances included into or onto articles and materi- each substance on the CL which can be down-
als with high or intended release during their service loaded by following the link: www.acea.be/
life from outdoor use. Such as tyres, treated wooden reach/publications/notification_factsheets
products, treated textile and fabric like sun blinds
and parasols and furniture, zinc anodes in commer-
cial shipping and pleasure craft, and brake pads in
trucks or cars. This also includes releases from the
article matrix as a result of processing by workers.
These are processes typically related to PROC 21, 24,
25, for example: Sanding of buildings (bridges, fa-
cades) or vehicles (ships). (ERC11a)
61
Working assumptions
NOTE
• First notification prior to 1 June 2011 is made on the According to Article 7.2 REACH, the calculation of
basis of the CL version of 1 Dec 2010. the concentration “0.1% w/w” refers to the article
• The tonnage has to be calculated for the year after the and not at the level of the sub-component weight.
substance appeared on the CL for authorisation. If company A imports an article from a non-EEA
• The notification of articles that contain a CL sub- producer and that same article contains a CL-
stance above a concentration of 0.1% w/w is trig- substance above the threshold and yearly tonnage,
gered when 1 tpa is reached. then a notification is required by company A. If then
• In case the 1tpa is not reached during the year after a company B assembles this article into a complex
the substance appeared on the CL for authorisation, article and the threshold and tonnage is still
the calculation starts again on January 1 following exceeded, a further notification is required. This
year, starting with “zero”. means that one notification is required to be made
• According to Article 7.7 REACH the notifier has a by company A acting as an importer and another
6 months window in which to notify after the inclu- by company B because he is an EEA producer of an
sion of the substance in the CL for authorisation. In article and the criteria for notification are met.
case the tonnage exceeds 1 tpa within this 6 months
AIG on REACH 3.1
one has to notify on the due date. Otherwise one has For more details refer to Articles 7, 57 and 59 REACH
to proceed collecting data till 1 tpa is exceeded and and ECHA “Guidance on requirements for substan-
then notify. ces in articles”
• Art 7 notification has to be done only once (for 1 CL
substance), not every year.
• If the tonnage range changes the notification has to
be updated.
• The quantities of the same CL substance in both im-
ported or manufactured articles for the same legal
entity has to be summed up for the tonnage calcula-
tion.
63
5.9.1 Recommendation for the By using IMDS it is recommended to avoid the use
Automotive Industry of wildcards and instead to work with the “confi-
dential substance” functionality.
By taking into consideration all criteria, the
2. Check if the CL substances have been registered by
following strategy for the automotive industry is
any supplier
recommended (refer to Flowchart 10):
a) As official and reliable source use the ECHA da-
tabase under: http://apps.echa.europa.eu/regis-
1. Check which CL-Substances are relevant for your tered/registered-sub.aspx
business b) For additional information ask the relevant asso-
a) Use results from the REACH TF SVHC Survey or of ciation/consortium/supplier or manufacturers
your internal investigations to evaluate the impact
on your business 3. Check if the CL Substances are exceeding the 1tpa
b) Use data from substance reporting systems to limit
check the 0.1 w/w threshold a) Use the results of your REACH Inventory and only
To get an overview about all CL-substances in your take into account in the calculation those parts
product portfolio, use the already established Sub- that you produce or import.
stance Reporting Systems (e.g. IMDS, MACSI) of
the automotive industry. The prerequisite for cor-
rect substance reporting is a continuously updated NOTE
declarable substance list (e.g. GADSL http://www. »» To simplify and justify your decision making pro-
gadsl.org) which contains those CL-substances cess, use the substance factsheet on notification
and regulated substances from other countries which can be found by following the link www.
being relevant for automotive articles. When new acea.be/reach/publications/notification_fact-
CL substances are added that impact the AI, an sheets
update of the GADSL list is undertaken by the re- »» In any case, the reasons for your decisions have
sponsible organisations. For those companies that to be documented
do not have an IT-tool available, alternative meth- »» In some cases it may be useful before going
ods can be used to collect the necessary data. through a lot of effort to get adequate informa-
tion to submit a notification.
By following the above recommendation, the main
task is to complete an inventory of CL-substances
in all articles produced and/or imported where
the concentration of a CL substance is above
0.1% w/w. Packaging is considered an article.
NOTE
According to the IMDS rules each user has to
check his existing IMDS data whenever a new
substance has been added to GADSL (e.g. new
CL substances). In case a new GADSL substance
is hidden in behind IMDS Joker, the user has to
update his Material Data Sheet by uncovering
this substance(s)!
64 5.10 Communication Requirements
for CL Substances in Articles
5.10
Communication requirements are already present Article 33.2 of REACH states that the information
in existing legislation applying to the automotive requirement must extend to consumers upon request.
industry, such as in Directive 2001/95/EEC on General The information must be provided to the consumer free
Product Safety or 2004/418/EC on the determination of charge within 45 days of receipt of the request.
of guidelines for manufacturers and dealers when
reporting hazardous consumer products to Member In cases where data is not available, a four-step
States. In general this means that goods supplied within approach is recommended;
our supply chain are considered safe.
• Ask your supplier (if still in business, if not, follow the
Article 33 REACH further requires that the supplier of next steps).
an article (see definition in Chapter 2.1) communicates • Undertake a risk based survey type analysis based on
information available on substances present in the your in- house knowledge to arrive at the most likely
article to the recipient in order to allow its safe use, areas of CL-Substance existence
including, as a minimum, the name of that substance. • Obtain robust and reliable data from similar prod-
uct groups and then use those findings to infer upon
Communication requirements apply to substances in articles where there is no information. This may be
articles meeting all of the following criteria: called “read across” process.
• As a last resort and in extreme circumstances, labo-
• The
substance is identified as of very high concern ratory tests can be carried out. At present this is not
according to Article 57 & 59 REACH (see Chapter 2.1 foreseen as being necessary or appropriate.
“Main Definitions” for “SVHC”) and included in the
CL for authorisation If templates are considered helpful please refer to
• The substance is present in the article in a con- Annex M “Article 33 answer letters”
centration above 0.1% weight by weight.
For more details on AI position regarding Article 33.1
For Article 33.1 REACH the information on CL- REACH please refer to Annex D “Frequently Asked
Substances contained in the article has to be provided Questions (FAQ)” and here especially to the Questions
automatically to the business-to-business recipient of 17 to 31.
the article. The following key messages of Article 33.1
REACH can be summarised as follows:
• Legacy
parts are within the scope of Article 33.1 REACH
• Packaging is an article, so the presence of a CL-Sub-
stance needs to be communicated if it exceeds the
0.1% w/w limit
• Professional customers are to be notified of CL-Sub-
stances automatically
AIG on REACH 3.1
5.10.1 Recommendation for the b) By using IMDS it is recommended to avoid the use of
Automotive Industry wildcards and instead to work with the “confidential
substance” functionality.
By taking into consideration all criteria, the
following basic strategy for the automotive industry c) According to AI agreement for assembled parts, com-
is recommended: munication has to be done on the level of the part
number.
As automotive parts are considered safe and informa-
a) Use the Substance Reporting Systems (e.g. IMDS, tion on safe use is given in the parts documentation
MACSI) together with a continuously updated declar- (e.g. user or workshop manuals) it is in most cases
able substance list (e.g. GADSL). For those compa- sufficient to provide the name of the substance in or-
nies that do not have an IT-tool available, alternative der to fulfil obligations under Article 33 REACH.
methods can be used to collect the necessary data.
NOTE
According to the IMDS rules each user has to
check his existing IMDS data whenever a new
substance has been added to GADSL (e.g. new
CL Substances). In case such a new GADSL
substance is hidden behind an IMDS Joker, the
user has to update his Material Data Sheet by
uncovering this substance(s)!
www.acea.be/reach
66 5.11 Authorisation Procedure
5.11
Substances fulfilling the criteria of Article 58 REACH »» DUs shall notify the ECHA within three months
and on the CL will most likely be added to Annex XIV of first supply of the substance if this substance
REACH. is used in accordance with the authorisation
granted for that use (Article 66.1 REACH).
In order to ensure “a high level of protection of human
health and the environment”, REACH Regulation sets
up the Authorisation procedure to permit a better
Authorisation in the supply chain
management of the risks associated with Annex XIV
SVHCs and progressively replace those SVHCs with If you are dealing with a substance included in
suitable alternative substances or technologies. Annex XIV there are additional obligations.
tonnage bands
»» DU may use a substance subject to authorisa- Exemptions to authorisation
tion provided that they use the substance in
accordance with the conditions of authorisa- (see also further exemptions in Chapter 5.2)
tion granted to an actor up the supply chain for
that use (Article 56.2 REACH). As mentioned the No application for an authorisation is required for a
“Guidance on the preparation of an application substance listed in Annex XIV REACH which is used
for authorisation” 2011/C 28/01, the term “use” in scientific research and development (PPORD). Such
is also defined via “Use Descriptors” system substances used for PPORD shall be specified in Annex
(refer to Guidance on information requirements XIV REACH as well as maximum quantity exempted
and chemical safety assessment Chapter R.12: (Article 56.3 REACH).
Use descriptor system)
67
Stakeholder Input
Stakeholder Input
Publication of ECHA End of Public ECHA transmits Recom- Commissions’ Commission Decision
Recommendations Consultation mendation to Commission Proposal (Art. 133.4) & WTO
(Public Consultation) Notification
Transmission to
MS Committee Inclusion into
Annex XIV
Minimum estimated
20
schedule and Annex I - How to use the REACH TF • Limit the use of substances included on the CL for au-
SVHC Survey V2_Final.pdf). thorisation while ensuring that the technical/quality
requirements are met and the socio economic impact
The whole process is based on cross company co- of substitutions has been taken into consideration.
operation. However, participating company names Thus, substitution must be carried out in agreement
are not disclosed. It is highly recommended to between customers and suppliers
support this process and to give input to the survey. • If you use a Annex XIV substance to produce an ar-
As IMDS is the main source for analysis, please ticle make sure that the manufacturer/importer of
make sure that your data is always up-to-date. the substance will authorise your use.
• Add to your supplier contract a clause that obligates
the supplier to inform you about their intentions to
authorise or substitute the Annex XIV substance.
70 5.12 Restriction Procedure
5.12
REACH foresees a restriction process to regulate Proposals for restrictions can be prepared by Member
the manufacture, placing on the market or use of States or by ECHA on request of the Commission. The
certain substances if they pose an unacceptable Restriction process is described in Title VIII of the
risk to health or the environment. The restriction is REACH and Annex XVII of REACH lists all restricted
designed as a “safety net” to manage risks that are substances and the conditions of their restrictions
not addressed by the other REACH processes. under REACH.
Prepa-
Submitter Prepare Restriction Dossiers
ratory Stakeholder Input
(MS or ECHA) (12 Month)
Work
Public
Public
Interested Notify Submit Consul-
Consultation
Parties tation
(6 Month)
(60Days)
Adopt a Draft
Econ. Opinion
Opinion
Committees
Analysis
(12 Month)
ECHA
Forum Advice
Commission Prepare
Amend Annex
(with Regulatory Decision
XVII
Committees) (3 Month)
Industry Comply
To facilitate open discussion and dialogue, Committees One main difference is that the import into the
for Risk Assessment (RAC) and Socio-economic EEA of articles is not covered by the authorisation
Analysis (SEAC), ECHA organises public consultation on obligation (an article imported in EEA, containing a
proposed restrictions. The consultation starts when the substance in Annex XIV REACH, is not concerned by
REACH Annex XV restriction report is published on the Authorisation obligation) whereas the Restriction
ECHA web page and is open for six months. Interested process can cover import of articles.
parties may comment on the proposed restriction and
the Annex XV REACH restriction report. Substances for which all uses are prohibited under
restriction procedure or under other Community
Stakeholders are invited to comment on the Annex XV legislation shall not be included in Annex XIV
dossier. It is highly recommended to provide comments REACH or shall be removed from it (Article 58(7)
within the first three months of the consultation period REACH).
in order to ensure your opinions and requests are
considered by others. Generally, the restriction process is the preferred
option in cases where it is justified to prohibit all
According to Article 68.2 REACH, a substance on its uses of a substance or to ban some (well known)
own, in a mixture or in an article which meets the uses because of unacceptable risks for man or the
criteria for classification as CMR 1A or 1B, and could environment.
be used by consumers and for which restrictions to
consumer use are proposed by the Commission, Annex
XVII REACH shall be amended without following the
Recommendation
complete procedure described below (Article 69 to 73
REACH shall not apply), particularly without consulting Similar to the automotive industry processes for
all interested parties (in accordance with the procedure authorisation, the automotive industry is also using
referred to in Article 133(4) REACH). for restriction the REACH TF SVHC survey in order
to generate an overview of the impact of possible
Until 1 June 2013, a Member State may maintain any restrictions on automotive business. It is thus
existing and more stringent restrictions in relation recommended to give input to that survey in order to
to Annex XVII REACH on the manufacture, placing on provide a representative overview.
the market or use of a substance, provided that those
restrictions have been notified according to the Treaty. Other documents on the subject
(REACH Title VIII-Chapter 1-Art. 67 REACH - Paragraph 3) Title VIII Article 67 to 73 REACH
• ECHA Guidance on Annex XV for restrictions
• ECHA Guidance on Socio-Economic Analysis -
NOTE Restrictions
Difference between Restriction and Authorisation
Process:
The restriction and authorisation processes are
related and can in practice have similar effect on
www.acea.be/reach
The definition of waste reads: “Waste shall mean any d) the use of the substance or object will not lead to
substance or object which the holder discards or intends overall adverse environmental or human health im-
or is required to discard” Article 3.1 Waste Framework pacts
Directive 2008/98/EC.
According to Article 2.7(d) REACH, recovered materials
Waste as defined in the Waste Framework Directive is can be exempt from registration, communication and
not considered a substance, mixture or article under evaluation, when the material
REACH (Article 2.221REACH). The reason for that is • is the same as a substance that has already been reg-
to ensure workability and to maintain the incentives istered
for waste recycling and recovery (Recital 11 REACH). • and
sufficient safety information according to REACH
Consequently REACH requirements do not apply to Article 31 or 32 is available for this recovered sub-
waste. Nevertheless, this does not mean that waste is stance.
totally out of the scope of the Regulation.
That means for recovered material the manufacturer/
According to REACH, manufacturers or importers importer has to ensure that the raw substances have
of a substance, in mixtures or in articles, subject to already been registered and a SDS for substances or
registration are indeed obliged to take the waste safety information shall be provided to customers for
life-cycle stage of the substance into account, where this recovered material.
relevant, in particular to create exposure scenarios. That
means they have to consider waste produced during Some recovery processes can also limit the obligations
the manufacturing and uses of substances. If relevant, under REACH. This is the case for example if at the end
waste produced during article manufacturing as well of the recovery process, the recovered product can
as waste linked to the end of article life containing be considered an article. In that case, there is no need
substances may need to be considered. to register (except substances intentionally released
from that article) since registration is only relevant to
As soon as a material ceases to be waste in a recovery substances. But the manufacturer or the importer has to
process it has to comply with the REACH requirements - comply with other obligations like Article 33 if relevant.
with a number of exemptions. Unfortunately at the time
of writing there is no clear definition available when
waste ceases to be waste with the exception of certain Note
metal scraps (see Council Regulation (EU) No 333/2011 The fulfilment of this obligation is considered
of 31 March 2011 establishing criteria determining to be extremely difficult because in most cases
when these certain types of scrap metal cease to be the communication chain between the article
waste under Directive 2008/98/EC). Member States producer and the recycler is disrupted. For further
may decide on a case by case basis when waste ceases information please refer to Annex L7 “Position
to be waste (Article 6.4 Waste Framework Directive) or Paper Spare & Used Parts”
criteria for the end of waste status will be developed for
AIG on REACH 3.1
Note
It must be stressed that even if there is no need
to register “impurities”, they have to be taken into
account for exposure scenarios, SDSs and other
risk assessments.
www.acea.be/reach
74 5.14 REACH-EN-FORCE-1
and REACH-EN-FORCE-2 Projects
5.14
REACH-EN-FORCE-2 Project • Inform dealers that they have to take care of all modi-
fications/parts they assemble to the vehicles that
REACH-EN-FORCE-2 project is the second EEA-wide have not been delivered to them by the OEM.
inspection/enforcement project that starts in summer
2011.
Practical REACH-audit example of the
automotive industry
It will focus on:
• checking the compliance of DU duties and An audit at an OEM Distribution Centre was carried
• the communication in the supply chain out by a Member States Competent Authority. The
warehouse of the OEM was inspected and two samples/
Previous results from REACH-EN-FORCE-1 project have products (glue and oil) were picked up during the
shown that it is useful to focus more than before on the tour through the warehouse. The representatives of
inspection of company internal information and control the Competent Authority asked to see the related SDS
AIG on REACH 3.1
mechanisms. Under REACH-EN-FORCE-2 there are also and compared the information on the label with the
inspections on Article 33 REACH compliance expected. information in the SDS. The inspectors recalculated the
hazard classification and compared their results with
the hazard pictogram and statement on the label of the
Recommendations of the Automotive Industry
product and it was found to be correct.
resulting from REACH-EN-FORCE-1 Project
and REACH-EN-FORCE-2 Project
• Build up company internal and external information Note
mechanisms with all your suppliers if not already It is not sufficient to solely place a SDS on a website
done (see Chapter 5.5.1 “How to communicate with but to actively provide the SDS to the customer.
the supply chain”).
5.15 List of ECHA Guidance Documents
75
REACH guidance documents provide supplementary All of the finalised Guidance Documents are available
information to the legal text. They cover all technical on the ECHA website at: http://echa.europa.eu/web/
aspects of REACH. These documents have been produced guest/guidance-documents/guidance-mainly-for-
with the assistance and endorsement of the Member industry-use
State authorities, the European Commission, NGOs and
industry. Therefore companies and authorities should ECHA is currently working on translating documents
use the guidance documents as the primary source of into all EEA languages. Also, contact your Member State
information when they need advice on how to fulfil REACH helpdesk for translations.
their REACH duties.
For further information see Annex G “Helpdesks and
Information tools”.
NOTE
REACH Guidance documents are subject to change
and are not legally binding.
www.acea.be/reach
76 Chapter 6: AIG 5 Step
REACH Compliance Schedule
6
Taking into consideration the results from the AIG vehicle manufacturers, indeed every company along the
Chapters 1-5, the following steps and tasks are supply chain should proceed as recommended below.
recommended for the automotive industry to fulfil the Please note that the AIG recommendations are general
obligations under REACH. As those obligations are the enough for company-specific interpretations. To get the
same for suppliers to the automotive industry as well as related Excel file please check the list of Annexes below:
The major recommendation of the AIG is to ask the non-EEA suppliers to establish
an OR within Europe. Regrettably this first priority can not always be adopted. If for
example suppliers are not willing to or are unable to establish an OR in the EEA further
options have to be considered and could be prioritised as follows:
1
• Priority 1: Ask supplier to establish an OR and to register
• Priority 2: Change your supplier or substitute the particular
substance/mixture
• Priority 3: Register by yourselves on behalf of your supplier or ask a service provider
to act on behalf of you.
The order especially of priority 2 & 3 is not fixed but depends on the company specific
policies and strategies.
1.2.3 If supplier does not intend to register, define your next steps/counter- 01/08 - ~
measures and communicate these to both customers & suppliers
Identification of Dangerous/Hazardous substances
Screen your internal databases for the use of the listed dangerous substances.
Existing substance reporting systems (e.g. IMDS, MACSI etc.) can be used for
inventory. Prerequisite for correct substance reporting is a continuously updated list
of declarable substances. When new SVHCs are added to the CL, an update of the
reported substance information is necessary.
Pre-Condition for compliance is that material reporting is completed!
77
Provide results of your internal investigation via the TF REACH SVHC
1.3.3 Survey to the TF REACH 10/08 - ~
1.3.5 Check if your identification of potential dangerous substances is correct once 10/08 - ~
the official CL/Annex XIV/Annex XVII is published
Tasks for Dangerous/Hazardous Substances
2.0 Communication
2.1.2 Check whether the related substances already have been registered
for your use today - ~
The registration needs not to be done by an actor of your supply chain but could also
be made by any other manufacturer or importer of the CL-substance. The use of the
affected CL substance must fit with the “use descriptor” of the registered CL substance.
ECHA webside
on registered Chapters 5.9
To check whether the substance in question has already been registered go to the ECHA substances &
website under the following link: http://apps.echa.europa.eu/registered/registered-sub.aspx & Flowchart 4.4
Substance Fact
Use the results of your REACH inventory and only take into account in the calculation Sheets
2
those parts that you produce or import. To check the registered use of the CL
substances in your articles (only those where the content exceeds 0,1% w/w) contact
the relevant association/consortium/supplier or manufacturers. If your use is registered
no notification is required. Otherwise check if the CL substances are exceeding the 1tpa
limit.
To simplify and justify your decision making process, use the substance factsheet on
notification which can be found by following the link: www.acea.be/reach/publications/
notification_factsheets
2.2 Authorisation
2.2.1 After publication/update of Annex XIV, check the sunset and latest 02/11 - ~
application date for each relevant substance.
After publication of Annex XIV: Contact your suppliers to make sure that
2.2.2 an apropriate substitute is available or the identified substances (Step 2.0) 02/11 - ~
www.acea.be/reach
After a substance has been included in Annex XIV: Contact your suppliers
2.2.4 ifapplication
you wish to authorise the use of the relevant substance or make an
yourself. Check SDS for the relevant substances to make sure 02/11 - ~
that the identified substance has been authorised for your use.
After the sunset date an Annex XIV substance cannot be used unless the
2.2.5 authorisation of use has been granted unless the Commission has not yet 08/14 - ~
adopted a decision and the application for authorisation of use was made
before the final application date.
78
6
2.3 Restriction
2.3.1 After publication/update of Annex XVII, check whether the conditions of IMDS combined
Chapters 06/07 - ~
restriction are fulfilled in your process & product with
In House Tools 4.7, 5.12
Start internal substitution process for Annex XVII substances if the
2.3.2 restriction is relevant or reduce the substance below the stated theshold. 06/07 - ~
Re-validation of the product will be necessary and a new Parts Approval
Process (PPAP).
Safety Data Sheets, Risk Management Measures, Exposure Scenarios
3.1 Check safety information documents for errors and shortcomings 06/07 - ~
(plausibility check)
3.1.2 Inform Producer (Supplier of substances or mixtures) about critical check 06/07 - ~
results and request an update of the document(s)
3 Exposure Scenarios as part of an extended SDS (eSDS) are available since end of the
first registration deadline on 1.12.2010
3.3 Comply with the RMMs mentioned in the safety information documents 06/07 - ~
Chapters
3.3.1 Make available SDS for the workforce (Article 35, REACH and Article 8,
98/24)
EDASx & EUPhraC, 4.9, 5.5, 5.6 06/07 - ~
Already existing
internal processes
Inform supplier about new findings concerning: & in house tools Annex
3.4 • Dangerous/Hazardous properties K, L6 06/07 - ~
• Insufficient Risk Management Measures (RMMs)
Use the substance only as allowed in the extended Safety Data Sheets
4.1
(eSDS) 06/07 - ~
Verify ES if the conditions of your use and your customers uses comply to
4.2 the prescription of your supplier (Identified Uses) 12/10 - ~
4.2.1 Check the use descriptors provided in the eSDS with regard to your use 12/10 - ~
Data Storage
5
Assemble and keep available all the information required to carry out your Already existing
internal processes Chapters
5.1 REACH duties for a period of at least 10 years after the last manufacture, 5.6, 5.15 06/07 - ~
import, supply or use. & in house tools
Submit this information or make it available without delay upon request to
5.1.1 any competent authority of the Member State where you are established 06/07 - ~
or to the ECHA.
The chart below is based on the chart presented in Chapter 3. In addition, it highlights the recommended timing for
the 5 steps, explained in the matrix above.
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Pre-Registration
Registration of Phase-in substances above 1000 tpa & CMR, R50/53 above 100 tpa & Substances for Authorization
Registration of Phase-in substances above 100 tpa
Registration of Phase-in substances above 1 tpa
Registration of non Phase-in substances and not pre-registered substances above 1 tpa
Candidate list (revisions)
Communication of Candidate list substances present in articles to downstream users/consumers (Art. 33)
REACH
Restrictions for the manufacture, use or placing on the market of substances (Art. 68)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
www.acea.be/reach
79
80 List of Annexes
In its chapters, the AIG is referring to a number of additional documents that are useful for further clarification and
may serve as tools to simplify the daily work.
Hereafter you will find a list of these documents. To download them, please click on your selected Annex. You will find
these documents included in the zip file. To download them again, please click on www.acea.be/reach/publications/
Guideline.