REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.

Registration

Registration requires producers and importers to submit information on chemical substances produced in or imported to the EU market in quantities above 1 t/year.

What to register?

It is important to note that only substances – no preparations or finished products are subject to registration.

Substances on their own or in preparations

Substances should be registered on their own or in preparations if the substances are produced or imported in volume >1t/year

Polymers are exempted from registration, however, monomers in polymers should be registered if the concentration is >2% weight by weight and the total annual volume is > 1t/year.

Substances in finished products

Substances in finished products should be registered if:

• they are intended to be released under normal or reasonably foreseeable conditions of use, and
• they are contained in volume > 1 t/y.

To assess the annual volume, you should check the volume of the substance contained in all products produced or imported per legal entity.

Substances in finished products should be first notified to the Agency if:

• the substances are meeting the criteria of Carcinogenic, Mutagenic and toxic to Reproduction, (CMR), Persistent, bioaccumulative and toxic (PBT), very Persistent, very bioaccumulative;
• the substance is contained in a product in volume > 1t/year,
• the concentration is above 0.1 % weigh by weight; and
• exposure cannot be excluded

The Agency may decide that registration is needed if there are “grounds for suspecting” that release of the substance presents a risk to health or environment.

Evaluation

Evaluation allows the regulatory authorities to assess whether information provided by industry is complete. They can decide whether more testing is needed if a substances may cause a risk to health or the environment,. Based on the information provided by industry, the authorities may decide that the use of a given substance should be restricted.

The Commission will prepare a 3 year rolling action plan setting priority substances for evaluation. The criteria for inclusion will be hazard, exposure and tonnage.

Authorisation

Members States authorities in charge of evaluation. The Agency will coordinate the process Authorisation of very high concern - carcinogenic, mutagenic, substances toxic to reproduction, and substances which are persistent, bio-accumulative and toxic, very persistent and very bio-accumulative or of equivalent concern cannot be produced, imported or used, unless an authorisation is granted for specific uses.

By June 2009, the Commission will suggest a candidate list of substances meeting the criteria of CMRs, PBTs, vPvBs. The candidate list is expected to include around 1500 substances. The list will not have a prohibitive effect and the use of the listed substances can continue. The Commission will select substances, assess them and decide if they should be restricted or not. If the Commission decides to ban a substance, it will be included in the Annex. It is from the moment of the inclusion of the substance in the Annex that the producers and importers will have to ask for authorisation for a specific use of the substance.

Restrictions

Any substance on its own, in a preparation or in an article may be subject to Community-wide restrictions if its use poses unacceptable risks to health or the environment. Restrictions can be decided either for the use of a substance in certain products, the use by consumers or even for all uses (complete ban of a substance).