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REACH entered into force on 1 June 2007 following publication of the text in the Official Journal as REGULATION (EC) No 1907/2006. Click here to view a pdf copy of the legislation. With 849 pages of legal text including the Annexes, it was a massive piece of legislation. Just before entry into force it was published in a different format as a Corrigendum thereby reducing it to 278 pages. As far as we understand it there is no change in the actual legal text.

REACH places important obligations on all actors in the supply chain: whether you are a manufacturer, importer, supplier, or downstream user, you really need to understand their duties placed upon them. REACHWise has wised up to the Regulation and can assist you in understanding your obligations - see for instance under Needs & Offering what you may require. Background on our expertise is also available on there.

A common misperception is that REACH starts to apply to substances manufactured or imported above 1 tonne per year. This is only true for the registration aspects; obligations, which may apply irrespectively of the volume, include obligations concerning use of the substance, restrictions, authorisation and communication in the supply chain, such as the provision of safety data sheets.

Main elements

The main elements of REACH are:

· Registration by industry of manufactured / imported chemical substances  > 1 tonne/year (staggered dead-lines over 11 years);

· Increased information and communication throughout the supply chain;

· Evaluation of some registered substances (Agency and Member States );

· Authorisation only for use of substances of very high concern;

· Restrictions: “Safety net” (Community wide action)

· Chemicals refers to substances on their own or in mixtures.

Registration

REACH has also clear deadlines (see picture below); whether it is pre-registration or registration - they will need to be met and it is best not to leave this until the last minute. To meet many of your responsibilities you may need to collaborate with other companies; this can be time consuming so it is best to make this part of your plans. REACHWise can help you with this and we work with other experts to ensure that the best team is available to help you.

Finally

Communication with the European Chemical Agency in Helsinki will mainly take place through the REACH-IT system of which IUCLID is a major element. We are currently involved in assisting with IUCLID5 training courses (for information click here). This is the only means of submitting the registration dossier to EChA. It also enables you to work effectively in consortia and a SIEF (Substance Information Exchange Forum, a legal requirement to avoid duplication of testing with vertebrates). Contact us to find out more to help you.

Restrictions

Why?

The restriction part of REACH aims to regulate the manufacture, placing on the market or use of certain substances if they pose an unacceptable risk to health or the environment. The restriction is designed as a "safety net" to manage risks that are not addressed by the other REACH processes.

When?

Any substance on its own, in a preparation or in an article may be subject to a restriction if it is demonstrated that risks need to be addressed on an EU-wide basis. A restriction dossier needs to justify that the proposed restriction is the most appropriate risk management measure to address these risks, and that no other mechanism is available.

Authorisation

The authorisation process starts the identification and inclusion in the "Candidate List" of Substances of Very High Concern, and the prioritisation of substances to be included in Annex XIV of REACH (the "Authorisation List "). So-called Annex XV dossiers may be prepared aimed to identify substances of very high concern. The outcome of this identification procedure is a list of substances ("the Candidate List"), which are candidates for eventual inclusion in the List of Substances Subject to Authorisation (Annex XIV of REACH).  

From this list ECHA identifies priority substances to be included in Annex XIV of REACH (the "Authorisation List") and then recommends Annex XIV entries for these substances to the European Commission.

Find out more >>>

Evaluation

The evaluation process applies to an individual dossier as well as to a substance. Certain dossiers will be evaluated “at random” because note every dossier will be selected, whereas for other dossier ECHA has a duty to evaluate them for example when tests on vertebrates have been proposed. In this case the Agency must do this within a strict time period.

To find out more about the stages to complete your registration dossier, either on your own or as part of a joint submission, click here.

REACH in more detail

Deadlines for registration