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Laws and regulations 30 March 2009
New EU cosmetics regulation: whats changing?
The European Parliament has adopted a final project to recast the European Unions
legislation on cosmetics. The new text changes the rules applicable to nano-materials
used in cosmetics, claims made for products, CMRs and in-market controls.
2/1/12 Premium Beauty News - New EU cosmetics regulation: whats changing?
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MEP Dagmar Roth-
8ehrendt rapporteur on
the recast oI EU
IegIsIatIon on cosmetIcs
AIter one readIng, the European ParIIament agreed on 24 March 2009 on a compromIse
text negotIated together wIth the CouncII and aImIng at sImpIIIyIng procedures whIIe
strengthenIng certaIn eIements oI the reguIatory Iramework Ior cosmetIcs.
A ReguIatIon to repIace the DIrectIve
The new IegIsIatIon wIII take the Iorm oI a European ReguIatIon, makIng It ImmedIateIy
enIorceabIe as Iaw In aII EU member states sImuItaneousIy. At the dIIIerence oI the
DIrectIve currentIy appIIcabIe to cosmetIc products [1], the new text wIII not need to be
transposed Into natIonaI Iaw In each member states, thus not gIvIng room Ior dIvergIng
InterpretatIons.
Strengthened In-market controI
As part oI the sImpIIIIcatIon oI admInIstratIve procedures, the text creates a sIngIe EU-
wIde regIster Ior cosmetIc products and Increases the cooperatIon between market
surveIIIance authorItIes.
n repIacement oI the varIous natIonaI procedures, the text Introduces an EU-wIde
compuIsory notIIIcatIon system oI cosmetIc products, IncIudIng the obIIgatIon to decIare
the presence oI substances In the Iorm oI nanomaterIaIs beIore pIacIng products on the
market. The requIred InIormatIon wIII be transmItted to the CommIssIon through
eIectronIc means.
UndesIrabIe sIde eIIects Induced by cosmetIc products wIII aIso be monItored at the
European scaIe.
CompuIsory IabeIIIng and saIety assessment oI nanomaterIaIs
For the IIrst tIme ever, a European IegIsIatIon addresses nanopartIcIes as such. As
requested by the European ParIIament, the new reguIatIon Introduces a saIety
assessment procedure Ior aII products contaInIng nanomaterIaIs, whIch couId Iead to a
ban on a substance II there Is a rIsk to human heaIth.
CosmetIc products contaInIng nanopartIcuIes wIII have to be notIIIed to the CommIssIon
sIx months prIor beIng pIaced on the market. n case oI concern regardIng the saIety oI
2/1/12 Premium Beauty News - New EU cosmetics regulation: whats changing?
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a nanomaterial, the Commision will have to seize the Scientific Committee on Consumer
Safety [http://www.premiumbeautynews.com/The-European-Commission,204] (SCCS
[http://www.premiumbeautynews.com/The-European-Commission,204]) for giving an
opinion.
Members of European Parliament (MEPs) also pushed successfully for any nanomaterials
present in cosmetics to be mentioned in the list of ingredients on the packaging. In the
list of ingredients, concerned substances will be followed by the word nano in brackets
(e.g.: Titanium dioxyde [nano]).
MEPs have also introduced a definition of a nanomaterial as an insoluble or bioresistant
and intentionall manufactured material ith one or more eternal dimensions, or an
internal structure, on the scale from 1 to 100 nm.
This is the first time that a definition of nanomaterials is introduced in European law.
The Commission will have to adapt this definition in line with scientific and technological
advances. However, environmental organisations and the BEUC [http://www.beuc.org/],
the European consumers organisation, have criticised the s narrowness of the
definitions scope.
Common criteria for product claims
On the use of product claims for cosmetics, the Commission is asked to adopt a list
determining common criteria. Such a list aims at harmonising the opinion of public
authorities in the various member states concerning what claims are acceptable or
unacceptable for cosmetic products.
Stricter rules on CMR substances
The regulation provides for strict rules for the use of substances which are carcinogenic,
mutagenic or toxic for reproduction (CMR). The use of those substances is basically
forbidden in cosmetics and they can only be used in exceptional cases under strict
conditions, which have been tightened up by the compromise.
The proposed text also addresses substances with endocrine-disrupting properties, that
will be regulated when European or internationally agreed criteria for identifying them
or at the latest five years after the Regulation has entered into force.
Ban on animal testing unchanged
The existing provisions banning animal testing for finished cosmetic products as of
2004, with a phasing-out period for animal tests on cosmetic ingredients by 2009/2013,
are unaffected by the new regulation
Final steps
MEPs adopted the proposed regulation with 633 votes in favour, 29 against with 11
abstentions. The Council must now approve the same text so that it becomes law and
comes into effect in 2012
Download text here:
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Recast of
cosmetic
products
legislation
Vincent Gallon
Footnotes
[1] Directive 76/768/EEC of 27 July 1976 and its several amendments
2009 - Premium Beauty News - www.premiumbeautynews.com
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