Posted: March 24, 2009

European Parliament approves new rules on safer cosmetics requiring labeling for nanomaterials

(Nanowerk News) Parliament approved an update of EU legislation on cosmetics when it votes on a first-reading agreement thrashed out between EP and Council representatives. The basic aim of the new regulation is to remove legal uncertainties and inconsistencies, while increasing the safety of cosmetics. Parliament's amendments add further improvements, especially regarding the claims companies make for their products and the safety of nanomaterials used in cosmetics.
This legislation has been guided through Parliament by Dagmar ROTH-BEHRENDT (PES, DE). Many of Parliament's wishes have been taken on board in the final text of the regulation. The legislative resolution was adopted with 633 votes in favour, 29 against with 11 abstentions.
Broad backing for Commission proposal
MEPs agreed from the outset with the Commission's approach of simplifying EU law on cosmetics by replacing the 27 sets of national legislation that enacted the old cosmetics directive with a single regulation - a standard legal text directly applicable in all Member States. They also supported the essential aims of the new proposal: ensuring a high level of safety of cosmetic products in future by strengthening manufacturer responsibility and in-market control aspects while cutting red tape. 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.
Nanomaterials: labelling, definition and safety assessment needed
If cosmetics ingredients include nanomaterials, as happens increasingly, safety concerns must be paramount, says the compromise between EP and Council.
The Commission estimated in 2006 that about 5% of cosmetic products contained nanoparticles. As requested by the European Parliament, the new regulation introduces a safety assessment procedure for all products containing nanomaterials, which could lead to a ban on a substance if there is a risk to human health. MEPs also pushed successfully for any nanomaterials present in cosmetics to be mentioned in the list of ingredients on the packaging.
Thanks to Parliament, a definition of nanomaterials is also introduced in the regulation and this must be adapted by the Commission in line with scientific and technological advances. The definition introduced by MEPs is as follows: "'nanomaterial' means an insoluble or bioresistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm".
Product claims: common criteria for use needed
On the use of product claims for cosmetics (such as claims about their effectiveness) the regulation seeks to ensure that only the real effects of a product can be mentioned in advertising and labelling. The Commission is asked to draw up an action plan on such claims and to adopt a list of common criteria for their use.
Substances classified as carcinogenic, mutagenic or toxic for reproduction
As proposed by the Commission and supported by MEPs, the regulation provides for strict rules for the use of substances in cosmetics which are carcinogenic, mutagenic or toxic for reproduction (CMR). The use of those substances is basically forbidden and they can only be used in exceptional cases under strict conditions, which have been tightened up by the compromise.
Date of entry into force
The regulation - which is directly applicable in all Member States - will enter into force 20 days after publication in the EU Official Journal. It will apply 42 month later - except for certain parts on CMR substances and nanomaterials, which will apply from an earlier stage.
Background: the 2003 cosmetics directive
The last time this topic came before Parliament, MEPs fought hard and successfully for a ban on sales of any animal-tested cosmetic products and ingredients, including those from outside the EU (see link below). Animal testing of finished cosmetic products was outlawed from 2004. In addition, bans were to be phased in for animal testing of cosmetics ingredients and also - to make sure that imports are covered - on any sales in the EU of animal-tested products and ingredients.
The deal will allow the continued use of ethanol in cosmetics, which is widely used and is the base of most perfumes. There are also provisions which will reduce the regulatory burden on industry, without lowering safety, which sit alongside a requirement to notify nanomaterials and to mark them on the ingredient list.
Source: European Parliament
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