CTPA Annual Report 2012 - page 10

Review of the Year
Biocidal Products Regulation
There are many safety regulations that apply to consumer
products. It is possible for cosmetic products to appear
to be caught by other regulations in addition to the
Cosmetics Regulation. These ‘borderline’ classification
issues are well-known and, usually, cosmetic products are
specifically excluded from such other regulations to prevent
confusion and a disproportionate regulatory burden.
Having mitigated last minute changes to the new Biocidal
Products Regulation that introduced the possibility of dual
regulation, CTPA and Cosmetics Europe thought the
outcome satisfactory, protecting the integrity of the
Cosmetics Regulation whilst allowing inherent biocidal
functions in a cosmetic and allowing the use of secondary
biocidal claims, such as ‘antibacterial’.
We were surprised, therefore, to find that the draft Irish
guidelines on the cosmetic product/biocidal products
borderline, heavily criticised during its consultation period
by the cosmetics industry, had been adopted as draft
Commission guidance by DG Environment, which leads on
biocides for the European Commission. DG Sanco, which is
responsible for cosmetic products, had not been involved at
that time. So a long rearguard action began to amend the
guidance, exclude cosmetics from the scope of the Biocidal
Products Regulation, and re-establish the primacy of the
Cosmetics Regulation for our products.
The biocides and cosmetics regulations work in totally
different ways. The Biocidal Products Regulation requires
pre-approval of each active biocidal ingredient followed
by approval for each product on the market using that
ingredient. Labelling is hazard-based.
The Cosmetics Regulations are based on a manufacturer’s
responsibility for placing a product on the market with no
pre-approvals as long as the manufacturer ensures the
product is safe and complies with the requirements and
restrictions laid down in the Regulation. This works in tandem
with effective in-market controls by the enforcement
authorities. Dual regulation, where a product must conform
to both sets of regulations is expensive, complex and,
for cosmetic products, does not improve consumer safety.
In the UK, the Health & Safety Executive (HSE), the UK
competent authority for biocides, and the Department of
Business, Innovation and Skills (BIS), responsible for consumer
safety legislation including cosmetics legislation, have given
us strong support. Cosmetics Europe has met with various
branches of the European Commission and provided
materials to national cosmetics associations to allow them
to have an informed discussion with their own national
competent authorities. In September, CTPA took part in,
and presented at, a commercial conference attended by
many national competent authorities for biocidal products,
making the case for maintaining the exclusion of cosmetic
products from biocides legislation.
By the end of the year, the situation had not yet been resolved
although the latest version of the Commission guidance has
improved but is still not satisfactory. Our advice is to continue
with the longstanding understanding of the cosmetic product/
biocidal product borderline as outlined in the old European
Commission guidance dating from 2002/2003. CTPA will
continue to promote the Cosmetics Regulation as the most
appropriate piece of legislation to manage the safety of
cosmetics whether or not they also have biocidal effects,
make secondary biocidal claims or contain preservatives.
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