Page 14 - CTPA Annual Report 2011

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04. Review of the Year
Chemicals Regulations
There are many regulations that affect the manufacture and use
of chemicals, including cosmetic ingredients. Implementation of
the REACH regulation will continue for several more years.
Large tonnage chemicals had to be registered by 1 December
2010 if they were to remain on the market; medium volume
chemicals must be registered by mid-2013. As users of
chemicals, we are primarily concerned with the loss of
ingredients if manufacturers fail to register in time and how
to deal with the mass of new information on how to manage
and use ingredients following successful registration. Importers
of finished cosmetic products also have registration obligations
for ingredients used in those products.
CTPA was also drawn into the development of the new
EU regulation on biocides. Under the existing Biocidal
Products Directive, cosmetic products are completely excluded
fromits scope. Many cosmetic ingredients, such as preservatives
or surfactants, do affect bacteria, moulds and fungi but their
safety is fully assessed under the cosmetics legislation.
Because of the intention of the new Biocidal Products
Regulation to cover anything with a biocidal effect, we found
our cosmetic products could be subject to both sets of
regulations. However, the UK’s Department of Business,
Innovation and Skills (BIS, responsible for cosmetics regulation)
and the Health & Safety Executive (HSE, competent authority
for biocides) were very supportive and helpful in negotiating
a satisfactory outcome, with Cosmetics Europe also making the
case to the relevant European Commission directorates.
A review of the scope of the directive controlling the emissions
of volatile organic compounds (VOCs) from products also looked
at cosmetic products with the intention of reducing the use of
solvents. Ethanol is the second most common solvent used in
cosmetic products after water, for example. After our industry
contributed information on costs that would be incurred and
the financial impacts for reformulation and loss of specific
product types, the European Commission eventually decided
that the relatively small reduction in VOCs would come at too
high a cost, especially when it is already successfully meeting
its overall targets for VOC reductions.
Cosmetics Regulation
The implementation of the new EU Cosmetics Regulation is
obviously of prime importance to our sector. Although the main
premise to only place safe cosmetic products on the market
remains, there are many changes that will impact companies
and providing clear interpretation to members to ensure
compliance with the July 2013 implementation date has been
key to CTPA. As well as developing common interpretation for
its members Cosmetics Europe is working with the European
Commission to develop guidance to complement the new
regulation in 4 major areas: notification, claims, the new
Annex I and the reporting of Serious Undesirable Effects (SUEs).
CTPA staff have been actively involved with the working
groups at our European association. CTPA is represented on
the committees discussing notification, claims, safety
assessment, nanomaterials, Product Information File and the
reporting of SUEs. This means CTPA has been able to feed
industry views directly into the discussions and conversely the
opinions of Member States and the Commission can be reported
back to members. CTPA was also able to seek the advice of its
relevant committees on critical questions – which has been
invaluable in the whole process of developing clear, meaningful
and workable guidelines on this major change in legislation.
Guidance issued so far includes:
• Roles and Responsibilities (of manufacturers,
responsible persons, distributors)
• Cosmetic Product Labelling
• Product Information File
• Notification System for all products placed on
the EU market
The documents are available to members in the
members' intranet.
Work continues on product claims, the new Cosmetic Products
Safety Report, the reporting of SUEs and the new requirements
for nanomaterials, including how to define nanomaterials used
in cosmetic products.
CTPA will be running its final seminar about the new regulation
in the first quarter of 2012. It will also be important to roll this
guidance out to the competent authorities responsible for
enforcing the new Regulation.