By: Ludger Möller

News and Views: High Priority

June 2008

Content:
REACH - the new European Community Regulation 1907/2006/EC on Registration, Evaluation, Authorization and Restriction of Chemicals.

Dear valued client,

On 1 June 2007 the new REACH Regulation on chemicals and their safe use came into force. In contrary to a directive, a regulation does not need to be transposed into the national legislation and is directly applicable in all member states.

The REACH regulation can be found at:
http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_396/l_39620061230en00010849.pdf
The authority responsible for REACH is the European Chemicals Agency ECHA:
http://echa.europa.eu/home_en.asp

The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances. This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. (Article 1)

One of its main instruments is the general obligation to register substances on their own or in preparations or articles. It will not be allowed to place substances or preparations on the market unless they have been registered in accordance with this regulation.

The below is a brief summary of the most important aspects. We hope that the provided information is helpful.

Best regards,

Ludger Möller
President
Medical Device Safety Service GmbH

REACH - the new European Community Regulation 1907/2006/EC on
Registration, Evaluation, Authorization and Restriction of Chemicals


Who may act as a registrant?

• Manufacturer (means any natural or legal person established within the Community who manufactures a substance within the Community) (Article 3)
• Importer (means any natural or legal person established within the Community who is responsible for import) (Article 3)
• EU-based representative of a non-EU manufacturer (called an ‘only representative’) (Article 8)

Manufacturers outside the EU are not covered by REACH. Either the importer of a substance manufactured by a non-EU enterprise performs the registration, or the non-EU manufacturer may by mutual agreement appoint a natural or legal person established in the Community to fulfill, as his only representative, the obligations on importers. (Article 8).

For more information on non-EU manufacturers, please see:
http://ec.europa.eu/environment/chemicals/reach/pdf/reach_non_eu_countries.pdf


What needs to be registered?

“Any manufacturer or importer of a substance, either on its own or in one or more preparation(s), in quantities of 1 ton or more per year shall submit a registration to the Agency” (Article 6). The registrations are substance specific and EU manufacturer/importer specific.

Substances falling under REACH:

• Phase-in Substances (for definition see Article 3 section 20) - Specific transitional provisions for phase-in substances are foreseen in Chapter 5

• Non-Phase-in Substances – Need to be registered immediately from June 2008 onwards

• Preparations: The preparations themselves do not need to be registered. However each substance which is contained in a preparation in quantities of > 1 ton per year needs to be registered

• Substances contained in articles need to be registered if both the following conditions are met:

• the substance is present in those articles in quantities totaling over 1 ton per producer or importer per year;
• the substance is intended to be released under normal or reasonably foreseeable conditions of use. (Article 7.1)

Substances of high concern contained in articles need to be notified if:

• the substance is present in those articles in quantities totaling over 1 ton
  per producer or importer per year
• the substance is present in those articles above a concentration of 0,1 % weight by weight (Article 7.2)

Are there any exemptions?

The Regulation foresees exemptions for several substances e.g. radioactive substances, non-isolated intermediates, non-hazardous substances listed in Annex IV etc.

Some substances (on their own, in preparations or articles) are excluded from certain Titles of the regulation e.g. substances in medicinal products for human or veterinary use, food additives etc.

Special provisions are foreseen also for plant protection and biocidal products if the active substances are manufactured or imported for use in such products only (Article 15).


What information needs to be submitted with a registration?

The registration requirements depend on the volume bands of the chemicals which are manufactured in or imported into the EU. The higher the volume or risk the more information is required. Carcinogenic or mutagenic substances, for example, require extensive registration information.

Manufacturers or importers of the same chemical substance need to join in a so-called SIEF (Substance Information Exchange Forum). All members of one SIEF must share the information of the substance and apply for a registration together. (see Article 29).


What are the timelines?

For phase-in substances EU manufacturers or importers may perform a pre-registration by submitting only limited information. This will allow them to benefit from the extended registration deadlines which depend on the substance and its volume bands. The pre-registration may be performed between 1 June and 1 December, 2008.

If EU manufacturers or importers do not pre-register the substances within the given timeframe, they will not be allowed to place them on the EU market before the regular registration was performed.


Impact on manufacturer’s of medical devices

In contrary to medicinal products, medical and in-vitro diagnostic devices are not excluded from REACH. Thus, also manufacturers of medical and in-vitro diagnostic devices are affected by REACH, if they place a substance (either on its own or in preparations or articles) in quantities of more than 1 ton per year on the EU market.

Preparation is defined as a mixture or solution composed of two or more substances.

Some examples from the medical device area:
Bone substitutes and cement, dental filling materials, lubricants and conductive media or contact lens solutions…

Article is defined as an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.

Some examples from the medical device area:
Cardiac pacemakers, catheters, corrective glasses, surgical instruments…


The manufacturer needs to determine for each preparation/article whether the REACH requirements are applicable or not. As indicated above, the volume bands and the toxicity have an impact on the obligation to register substances.


Safety Data Sheets

One aspect which needs to be considered even though there is no obligation to register a substance under REACH is the material safety data sheet. As outlined in the introduction (p. 39), the REACH regulation replaces the Commission Directive 91/155/EEC defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations. Thus, for all substances which require a safety data sheet, the requirements set out in Annex II of the REACH regulation need to be fulfilled.


Useful Links:

General Information / Overview
http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

REACH in brief
http://ec.europa.eu/environment/chemicals/reach/pdf/2007_02_reach_in_brief.pdf

Questions and Answers on REACH
http://ec.europa.eu/environment/chemicals/reach/pdf/qa_july07.pdf

Website of the European Chemicals Agency ECHA
http://echa.europa.eu/home_en.html

Guidance Documents
http://reach.jrc.it/guidance_en.htm


The above information is only a very brief summary of the new REACH regulation prepared by MDSS. MDSS cannot be held liable or responsible for the content of this summary. If you would like to find out if and to what extend you are affected by this regulation, please always refer to the original legislation. Please consider to consult a specialist before you take any measures or actions.

Author:
Bianca Rieger, RA/QA Assistant
Medical Device Safety Service GmbH


Best regards,

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