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, bio-accumulative and toxic (PBT), very Persistent, very bio-accumulative;
  • the substance is contained in a product in volume > 1t/year,
  • the concentration is above 0.1 % weight 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 substance 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

Authorisation is a process which starts with the identification of Substances of Very High Concern (SVHC), which is done by the EU Member States together with ECHA (the European Chemicals Agency) on the Candidate List. The identification is followed by priority setting of substances. ECHA makes a recommendation to the European Commission on which substances should be prioritised to be restricted. Based on this recommendation the Commission decides if a substance should be banned by including it in Annex XIV. From that moment on producers, importers and downstream users will have to ask for authorisation for a specific use of the substance.

Around 2000 substances are eligible for inclusion on the Candidate List, however these substances will be gradually included. The first list of substances with candidates for a potential ban was published in October 2008 listing 15 substances. It will be updated twice a year, in December and June. The list will not have a prohibitive effect and the use of the listed substances can continue. However, as soon as a substance is published on the candidate list there are immediate obligations .

 

Restrictions

From 1 June 2009, the REACH restriction process entered into force. Member States or ECHA (on behalf of the Commission) can start a process to restrict the manufacturing, placing on the market or use of a chemical substance. 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. The Commission is currently working on the restriction of several substances. Restrictions can be decided either for the use of a substance in certain products, the use by consumers or for all uses (complete ban of a substance).