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e g u la ar e a
R future and regulation
Children, our future, we should take care of their safety in more
careful way, but for the purpose of manufacturing and safety
assessment which are the regulatory limits?
The definition of children may be different from one country to
another or accordingly scope and regulation.
As an example of this, the EU toys regulation has the limit
of 14 years old, in the Brazilian cosmetic regulation the age
limit is 12 and the same is for China. The European regulation
1223/09 clearly identify the age of 3 asking for a specific safety
assessment of the product and in the meanwhile specific
limitations are given for some ingredients or applications. In the
USA, with the exception of color additives and OTC, regular
cosmetic products and ingredients are not required to be
registered before being placed on the market in the light of
current laws.
Based on this, discussion of this topic from a regulatory
perspective could be quite easy: you should identify the purpose
of the product, the age limit and act accordingly. Quite clear,
but the point is usually the question that is raised immediately
after: do you have guidelines? How the safety assessment is
different, based on what?
The answer is not, obviously, in a specific regulatory text so I
will try to encompass some suggestions that can be used to
achieve the goal of a deeper safety assessment. Many points
are collected from few interesting documents that address this
point from an official perspective:
• a specific guide published after the resolution of Council of
Europe (1) from the European Directorate for the Quality of
Medicines (EDQM) of the council www.edqm.eu
• the THE SCCS’S NOTES OF GUIDANCE FOR THE TESTING OF
COSMETIC SUBSTANCES AND THEIR SAFETY EVALUATION
SCCS guidelines 9th edition
• a guideline from Chinese State Food and Drug
Administration (SFDA)
• other sources of official authorities
We will not consider in this short excursus the specific area of
cosmetic toys, only a remind
that, if this is the case, the
product must comply also to
the toys regulation with specific
and different limits: it is obvious
that the stricter limit of both
regulations will apply.
Let’s try to have a summary of
the points.
26 H&PC Today - Household and Personal Care Today, vol. 12(3) May/June 2017
Baby, children:
AGE
A product must be clearly identified to be used under a
specific age, a generic shampoo is intended to be used
from everyone and the choice to use it also under the
specific age (3 years old in Europe, 12 years old in China
and Brazil) is left to each consumer. No specific label is
required for this, meaning that a manufacturer that claims
the use for these categories must affirm this in a positive
and clear way.
For the purpose of safety assessment it should be underlined
that, if a foreseeable use can be imagined for a product
under the age limit as mentioned, this must be considered for
the assessment. As example think to a shampoo promoted
as very mild, will be used for children; an eye anti-age serum
probably not.
Manufacturers (and/or safety assessors) should consider
the opportunity to label sensitive products with a standard
warning “not to be used for children” “keep away from
children” or even more strict requirements. To be remembered
that warnings must be translated in each language. In Brazil a
specific list of warnings is defined in the regulation of 2015 with
the definition of the age limits.
This point is more clear in China rules as Chinese product
name, labeling and instruction for use shall contain clear
statements such as “intended for use on children”. Meanwhile
warning statements like “intended for use on children, must
be used under the supervision of an adult” shall also be
marked on the outer packing.
Aside the regulatory limits (as given in EU, China and Brazil),
in order to be clear when managing this kind of products, it is
useful to fix the
AGE-RELATED TERMINOLOGY
This table is useful when connected to the ratio between the
surface area and body weight compared to adults:
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GENERAL PRINCIPLES
It is quite long to go into details of the reasoning for each
choice so I will simply fix the points, it should be in any
case easy to understand the rationale.
A non-complete list of points (for safety assessment or/and
regulatory request)
to be considered developing a baby or children product
The product
• The product must be safe in normal and all
foreseeable conditions (in looking at this do not cut
corners avoiding some points, be inventive as children
and mothers are more inventive than you !)
• The presentation of a cosmetic product for children,
and especially their shape, smell, color, appearance,
packaging, labeling, volume or size, should not
endanger their health or safety by confusing it with a
food. This is sometime a critical point; marketing
pressure could be in the opposite direction looking for
attracting colors and shapes. It must be remembered
that babies and children often use the mouth to
explore the world. The point is specifically cited in the
EU regulation 1223/09, but in this case the criteria must
be satisfied for sure
• substances classified as
carcinogenic, mutagenic,
or toxic for reproduction
must not be used
• substances with known
(or in some cases also
suspected) endocrine
disruptor activity should
be avoided;
• substances that comply with criteria to be included in
annex XIV of regulation (CE) No 1907/2006 (REACH)
are not to be used;
• substances that have strong allergenic potential
should not be used. In this area, the opinion of SCCS is
very useful as the list is quite comprehensive. Do not
limit the choice avoiding the allergens cited in annex
III of EU regulation as this may be questioned.
Hypoallergenic claim
The last available draft of annexes at regulation
655/13 on cosmetic claims is dedicated to the term
“hypoallergenic”, a very appealing and easy to
misunderstand claim for this category of products.
“Hypoallergenic”, also for standard adult products, can only be
used in cases where the cosmetic product has been designed
to minimize its allergenic potential. Scientifically robust and
statistically reliable data are needed to justify the claim and this
assessment should be updated continuously in light of new data.
Planning the formula of a baby product is quite difficult
and the choice to claim also “hypoallergenic” is, to some
extent, dangerous.

The concept of safety

• remember the fact that, proportionally to their mass,
the body surface of children of 0-3 years is more
important than that of adults and that functional
maturity of the metabolic systems may not be
stabilized before 2 years of age,
• consider specific conditions of exposure, especially
the nappy area,
• different types of products, especially not-rinsed
products can be applied several times a day with no
limit (do not underestimate) or in combination with
many others.

The ingredients
• try to use the lowest number of ingredients, this is a
good choice to minimize potential toxicity
• achieving product performance with less or without
perfumes, colorants, preservatives and surfactants, as
well as paying attention to potential sensitization
hazard;
• choose ingredients and technology with a history use
sufficient to ensure safety. New technique and
advanced materials such as gene technology and
nanomaterials are not the best choice in this area;
• make an in deep exercise to check the source,
composition, impurity, physic-chemical properties,
scope of applications, safety dose and other
information of each ingredient in formulations
If a cosmetic product claims to be hypoallergenic, the
presence of known allergens or allergen precursors should
be totally avoided, in particular of substances or mixtures:
• identified as sensitizers by the SCCS or former
committees assessing the safety of cosmetic
ingredients;
• identified as skin sensitizers by other official risk
assessment committees;
• falling under the classification of skin sensitizers of
category 1, sub-category 1A or sub-category 1B, on
the basis of new criteria set by the CLP Regulation;
• identified by the company on the basis of the
assessment of consumer complaints;
• generally recognized as sensitizers in scientific
literature;
• for which relevant data on their sensitizing potential
are missing;
Given these limitations and the fact that experimental
induction tests, such as the Human Repeated Insult
Patch Test (HRIPT) and the Human Maximization Test
(HMR) are no longer performed for EU regulations due
to ethical reasons and cannot be used to support the
hypoallergenic claim this point should be out of the
discussion.
The more the R&D department should consider also the
above-mentioned points in the choice of ingredients and
specifically the perfume.
So, the claim “hypoallergenic” is not for baby or children
products.
Extra Requirements
An important part of a safety assessment is based on
testing, in order to comply to the need of a more detailed
assessment a specific attention should be given to testing.
Care must be needed in the choice of the tests and in the
interpretation of results
• Phototoxicity, sensitisation, skin and eye irritation:
the formulations shall not have any relevant adverse
effects, no compromise should be accepted
• Challenge test must be done taking in consideration
the specific use of some products that may be
overexposed to some contaminants.
• Extra safety assessment is needed of perfume, organic
solvent, cationic surfactants, penetration enhancers
and other ingredients depending on how cosmetics is
used (for example, whether a cosmetic product is to
be rinsed or not after use);
• The EU annex III and China list of ingredients have
specific restrictions on some ingredients such as
terpenes, only as remind
• Some fragrance materials have been limited (2) and
should be avoided
- Safrole
- Camphor (max 0.015 %)
Please send your reaction/comments/topics you would like to analyze to Dr Gayle De Maria
at gayle@teknoscienze.com placing in the subject line “regulatory area”.
28
- Eucaliptol (max 0.1 %)
- Menthol (max 0.45 %)
Microbiology
With respect to the microbiological specifications, a
specific low limit value of not more than 10 2 UFC/g or mL in
0,5 g o 0,5 mL. Pseudomonas aeruginosa, Staphylococcus
aureus and Candida albicans must not be detectable in
0,5 g o 0,5 mL of product. The ISO 21148 norm should be
considered and also, as previously noted, the challenge
test should be severe and conducted taking count of
some specific contamination that can happen during the
use of the product in the nappy area.
Reference for this can be found in »Notes of Guidance for
Testing of Cosmetic Ingredients for Their Safety Evaluation«
from SCCS
Packaging
Also for this point a specific attention is needed, shapes
should be examined from the intended use:
• Opening system should be preferably child safe
• The container should be designed in order to avoid
risk of sharp surfaces and avoid physical lesions
• Avoid glass bottles or materials that can be slippery
when used with wet hands
• Caps and other detachable parts should be with
dimension that avoid the ingestion (the test EN 71 that
is designed for toys is a good reference)
CONCLUSION
The age class of products for children up to 12 years old,
as defined in China and Brazil, are a good exercise to be
innovative and find solutions and arguments. It is not a
real formulation problem; some care should be made in
the choice of ingredients and safety assessment should be
accurate.
Product designed for babies under 3 years old are a
real challenge for R&D and safety assessors, but can
be successfully managed. The design must be wise and
accurate from beginning while the R&D, marketing and
regulatory/safety must exchange in a collaborative way
info in order to have a performing, safe and successful
product for babies, our future.
GIULIO PIROTTA
Neovita consulting
Uboldo (VA), Italy
H&PC Today - Household and Personal Care Today, vol. 12(3) May/June 2017