Introduction to the REACH REGULATION

The new European Union chemical policy, REACH (Registration, Evaluation and Authorization of CHemicals), is aiming at ensuring a high level of protection of health and the environment as well as enhancing innovation of green chemicals.

The Regulation (EC) N°1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of chemicals (REACH) and Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC (relating to the classification, packaging and labelling of dangerous substances) were published in the Official Journal on 30 December 2006.

REACH comes into force on 1 June 2007. This new regulation replaces around 40 existing EU Regulations and Directives so as to provide a single system to regulate chemicals in a more organized manner.

Who does it affect?
REACH applies to manufacturers, downstream users and importers of chemicals within the EU. They have to prove that substances are safe to use and that they control the risks to human health and the environment. Retailers and distributors also have obligations related to communication in the supply chain.

What will change with this new system of chemicals management?
Under the present legislation public authorities are required to identify and address possible safety issues for the chemicals on the market. REACH aims at changing this balance by requiring industry to take responsibility for assessing the risks of chemicals and for ensuring their safe use. At the same time, improvements in the efficiency of the system are designed to ensure that there are better incentives for developing new and safer chemicals and that the requirements are drawn up in such a way that the competitiveness of EU industry is safeguarded.

Then, industries will be responsible for declaring uses of chemical substances in order to assess the risks inherent in the use.

The REACH implementation project (RIP) carried out a close collaboration between commission services and stakeholders, member states and industry. Technical guidance documents are prepared for industry and authorities to facilitate the implementation of the future REACH regulation. It will help to understand tasks and fulfil obligations under REACH.

REACH is a Communication, Coordination and Cooperation challenge at 3 levels: intra-company, inter-company, multi-stakeholder level.

Which products are affected by the REACH system?
All substances with a threshold limit of 1 tonne per annum are covered by this regulation except those expressly exempted in the Regulation. Both existing and new chemicals are concerned.

The importance of the required documents will depend on the tonnage of production.

There are two levels of exemption:

I. Substances not regulated by REACH

Radioactive substances
Re-exported substances
Non-isolated intermediates
Wastes

II. Specific exemptions
Certain group of substances may exempt from some procedures under REACH:

   Key
   II      Registration
   IV    Information in the supply chain
   V     Downstream users
   VI    Evaluation
   VII   Authorization

Substances exempted from Titles II, V, VI, VII

Medicinal products (726/2004/EC, 2001/82/EC,2001/83/EC)
Food or feeding stuffs (178/2002/EC)

Title IV shall not apply to preparations intended for final use:

a) Medicinal products (726/2004/EC, 2001/82/EC,
2001/83/EC)
b) Cosmetic products (76/768/EEC)
c) Certain medical devices (90/385/EEC, 93/42/EEC,
98/79/EC)
d) Food or feeding stuffs (178/2002/EC)

Substances exempted from Titles II, V, VI

a) Substance considered to cause minimum risks (Annex IV)
b) Substances inappropriate for registration (Annex V)
c) Identical substances re-imported within the same supply chain
d) Recovered substance which have been registered already

Substances exempted from Title II (except art 8 and 9), VII