The EU's chemical control system, REACH came into force on 1 June and is possibly the most complex piece of legislation issued by an international organisation known for its administrative and legal complexity. Here's what the cosmetics industry needs to do when
Of key concern to cosmetics businesses are REACH rules on chemical 'preparations'. Under REACH this “means a mixture or solution composed of two or more [chemical] substances”. As a result this covers many processed cosmetics, such as sun lotions, essential oils, soaps and scents, so companies making these products or importing them had better be sure they have registered chemicals used in these products with the newly formed European Chemicals Agency (ECHA) in Helsinki, or are complying with REACH guidelines on their use. If not they or their suppliers may find themselves in breach of the law and unable to import, make or use a particular input or preparation. That said, it is worth pointing out that REACH does not cover naturally occurring substances such as many biological oils, but it does cover the chemically altered products derived from them.
And from now until 2022, a series of deadlines will pass, telling a company handling, importing, processing or making chemicals to register, test, assess and certify these commercially crucial substances.
Under the rules for preparations:
- If a cosmetics company buys a preparation from a European manufacturer, there may be no [immediate] obligations under REACH. The manufacturer should have a safety data sheet for that preparation.
- If a company buys a preparation from outside the EU, all its chemical components must be registered with the ECHA.
- If a manufacturer of a preparation buys a chemical component from a manufacturer in the European Economic Area [the EU plus Norway, Iceland and Liechtenstein], there are in principle no obligations under REACH, other then to communicate to that supplier how you are using the substance.
- If a manufacturer of a preparation imports a chemical component of a preparation, that substance must be registered.
- Manufacturers of a preparation that have been registered by someone else have to ensure their use of the preparation is covered by the registration document, notably that its use does not expose people or the environment to a chemical beyond that accepted in this official declaration.
_ If not, a manufacturer can go back to a supplier and ask them to extend the registration, or can inform the chemical agency of that use and demonstrate to the agency that it can guarantee the safe use of this substance within the preparation.
- If it does not have a valid registration, it will have to stop manufacturing or importing.
So, there is much to do.
Where a cosmetics company has to provide a registration, it involves providing information abut its classification, identity and use, in a format as laid down in Annex VI of the regulation.
Separate rules apply for 'articles' - goods that take their form from a manufacturing process separate from their chemical inputs, and although for the cosmetics industries they are less important these have to be considered for some sold goods such as razor lubrastrips and especially as regards packaging. For a bottle, a can, a tube casing, even a vat, are all objects rather than preparations, and they also will contain chemicals, such as the inks in their labels and the colourants used in their plastics; although polymers themselves are not generally covered by REACH.
“For new substances the rule is simple: if registration is required from now on, and there is no registration, sales or use in the EU of products containing them are banned” |
And the problem here is that there is currently a sensitive and potentially controversial debate at the European Commission about interpreting REACH that could have a major impact. This is about what is an 'article'? Is it a bottle of suntan oil or the bottle and the suntan oil individually. Is it a tube of moisturiser or a tube and its moisturiser apart? This could affect the formulae under which companies decide whether they have to register a chemical in these 'articles'.
They must do so under two sets of circumstances:
- If a chemical substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year;
- and “is intended to be released under normal or reasonably foreseeable conditions of use”.
So if a cosmetics packaging, say, emits strawberry smell, a manufacturer and importer may have to register this chemical. But of course packaging is thrown away so it could well be deemed to be 'intentionally released'. And here's the rub. A lipstick casing's lipstick is applied to the face. If the lipstick casing is considered a separate article, its disposal and release into the environment could be deemed part of its design, and so the chemicals used in its manufacture may need to be registered.
Also, under a second set of circumstances, registration is required if an article is deemed by the agency potentially of concern to health or the environment; and makes up 0.1% or more by weight of an article, as well as weighing more than 1 tonne given the amount of a particular article imported or made annually by a company, regardless of its release. If the 'article' is deemed to be a bottle of hand soap, as one single item, the chances of any chemicals in the packaging making up more than 0.1% of the overall weight would then be slight. But if the bottle, the soap and a paper label were all considered separate articles, then the inks used in a label may make up 0.1% of the weight and would be caught.
So, much work, but fortunately it is not due all at once.
As regards registration, deadlines vary according to the importance or toxicity of a chemical substance. For existing substances deemed by the agency to be carcinogenic, mutagenic or toxic to reproduction, as well as substances produced or imported by an applicant in volumes exceeding 1,000 tonnes a year, the deadline is 1 December 2010. For those produced or imported in volumes exceeding 100 tonnes annually it is 1 June 2013. And for smaller volume substances exceeding one tonne annually it is 1 June 2018.
Meanwhile, some preparation for this registration needs to be completed in most cases by 1 December 2008, which is the deadline for the so-called pre-registration process. This involves the agency being given basic information about the product which will be registered, such as a definition of the substance, how much is produced or imported (roughly) and some contact details.
For new substances, however, the rule is simple: if registration is required from now on, and there is no registration, sales or use in the EU of products containing them are banned.
Also by June 2008, member states are supposed to have forwarded to the ECHA existing risk information about chemicals and related substances that already have market approval. And by 1 August the agency is supposed to have received notification from manufacturers and importers of new chemical substances that have been officially declared to regulators but have yet to hit the market.
Another key date is 1 June 2009 when the second pillar of REACH, its special authorisation procedure saying how chemical substances deemed particularly hazardous can or cannot be used, comes into force. This is when the chemicals agency makes its recommendation for substances that must be subject to a rigorous screening process detailed in the REACH regulation's Title VII.