Biomedical Engineering Reference
In-Depth Information
The Commission will carefully follow developments, and report back to the Parliament, the Council
and the European Economic and Social Committee within 3 years.
*
Much of this language is of the same substance and tone as that quoted in the various FDA
guidances earlier in this chapter. The key difference is whether the comments from the FDA relate
to products incorporating nanomaterials rather than to the materials themselves.
15.9.1 c
osMetIc
d
IrectIve
There have been specific product class developments within the EU in this time period relating to
cosmetics, food and related items, biocides, and medical devices and pharmaceuticals. The major
development regarding cosmetics is Regulation (EC) No. 1223/2009, passed by the Parliament and
Council on November 30, 2009. The regulation became effective on July 11, 2013, and replaced
the “Cosmetics Directive,” which in the words of the announcement “ensured that products circu-
late freely whilst guaranteeing a high level of protection for consumers.”
†
The provisions of No.
1223/2009 “aim at ensuring that consumers' health is protected and that they are well informed by
monitoring the composition and labeling of products. The Regulation also provides for the assess-
ment of product safety and the prohibition of animal testing.”
‡
The regulation includes specific
provisions for nanomaterials (definition, requirements for notification, labeling and reporting of
nanomaterials). There is also a Cosmetics Product Notification Portal, a central system where a
distributor will have to submit information on the presence of nanomaterials in cosmetics, as well
as plans for a guidance for safety assessment of nanomaterials in cosmetics.
§
The provisions of the
regulation go a considerable way to satisfying the objectives of identification, registration (notifica-
tion), safety labeling, and data collection and assessment. It is an advance on the somewhat tepid
guidance on cosmetics issued by CFSAN in the United States.
The regulation continues to provide that free movement of cosmetics in the internal market
is permitted if they comply with the provisions of No. 1223/2009. Compliance rests in the first
instance with the entity distributing the cosmetic. A responsible person must be designated for each
product placed on the market, and the responsible person is charged with ensuring compliance of
the cosmetic products with the rules set out in the Regulation, especially those relating to human
health, safety, and consumer information. The responsible person is obliged to maintain a product
information file accessible to the public authorities, and furthermore, he or she has to identify the
distributors to whom they supply the cosmetic product for a period of three years following the date
on which the batch of the cosmetic product was made available to the distributor. The same applies
to all other persons involved in the supply chain.
If a product does not comply, a responsible person is directed to take one of the two actions to
render it compliant: (1) withdraw it from the market; or (2) recall it to the manufacturing company
in all member states where the product is available. Where the responsible person does not take all
appropriate measures, the competent national authorities are empowered to take the necessary cor-
rective measures.
If a product which complies with the requirements of the Regulation presents or could present a
serious risk to human health, the competent national authority shall take all necessary provisional
measures to withdraw, recall, or restrict the availability of the product on the market.
The Annexes of the Regulation provide lists of prohibited or restricted substances with respect
to use in cosmetic products. Certain colorants, preservatives, and UV-filters are also prohibited.
*
Id.
at 11.
†
Europa. Summaries of EU Legislation. Cosmetic Products (from 2013). http://europa.eu/legislation_summaries/
consumers/product_labelling_and_packaging/co0013_en.htm.
‡
Id.
§
Developments in Nanotechnologies Regulations and Standards 2012—Report of the Observatory Nano at 6.
