About REACH

On 29 October 2003, the European Commission adopted a proposal for a new EU regulatory framework for chemicals. Under the proposed new system called REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register it in a central database.

The aims of the proposed new Regulation are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information would be passed down the chain of production.

The proposal has been drafted in close consultation with all interested parties, including an Internet consultation. The new rules, which will come into effect from June 2007, will require importers and manufacturers of chemicals to provide health and safety data for some 30,000 substances currently used in everyday products. These range from plastics used in computers and mobile phones to substances used in textiles, paints, furniture, toys and cleaning products.

Registration

All must be registered over an 11-year period within a new chemicals agency to be set up in Helsinki. The registration process will begin with the most toxic chemicals as well as those marketed in higher volumes.

Producers and importers of chemicals, not authorities as is currently the case, will need to show that substances are safe before they can be placed on the market (reversal of burden of proof). An agency will be set up to authorise or reject the applications. Safety screening and registration will take place in three stages, based on two broad sets of criteria:

• Volumes produced or imported per year: >1000 tonnes within 3 years; 100 - 1000 tonnes within 6 years; 1 - 100 tonnes: within 11 years, and;
• Risk: highly hazardous substances will be assessed in priority within the first three years. These are: CMRs (carcinogenic, mutagenic or toxic to reproduction), PBTs (persistent, bio-accumulative and toxic), vPvBs (very persistent and very bio-accumulative) and other substances "of equivalent concern"
  Authorisation will be granted to these substances only if risks can be "adequately controlled" or on valid socio-economic grounds if there are no alternatives

The REACH proposal covers about 30,000 of the 100,000 'existing substances'. This is because it leaves out substances that are imported or produced in less than one tonne per year, others are exempted if they are controlled by other regulation. Under the previous system, 'new substances' had to go through safety screening if they were imported or produced in quantities of more than 10kg per year.

The legal text

The text of REACH (849 pages with Annexes) has been published as EC Regulation 1907/2006 on L396 issue of the Official Journal of the European Union. The Commission has made two Question and Answer files. The first file describes the main points of REACH very briefly, the second file describes some of the questions that inevitably comes up.

REACH in Azelis

REACH will require a lot of work for all companies in the EU with regard to pre-registration and registration of manufactured or imported chemicals. In Azelis we started to focus on REACH as early as 2003. Early 2006 we started the preparations for the pre-registration.

The most important thing is to map our own import of chemicals and preparations into the EU. The mapping is done with respect to tonnage, substance, use and classification by our REACH Core Team, which consists of technical, marketing and sales people in close cooperation with product responsible managers and top management.

One of the other things that we have done is making a brochure to raise awareness of our non-EU suppliers. This brochure, 'REACH - Preparing for the future' can be downloaded here. The brochure has been the starting point for further discussions on responsibility and data requirements.

See also our REACH Information bulletin here.

If you want to know more about REACH either in general or in Azelis, please contact:

Birthe Oldenborg
Quality & Environmental Manager
Phone: +45 45 26 33 55
Email: birtheo@broste.com

or

Stefano Colicchia
Quality System and Product Safety Manager
Phone: +39 02 48479.223
Email: stefanocolicchia@azelis.it

or visit these web pages:
The Commission
European Chemicals Bureau - for guidelines see The final reports of RIPs (REACH Implementation Projects)
Euractive