Informations about REACH

What is REACH?

The abbreviation "REACH" stands for Registration, Evaluation and Authorisation of Chemicals".

REACH is based on the principle, that manufacturers, importers and also downstream users must guarantee, that substances they manufacture or bring in circulation, do not damage human health or the environment. These regulations are based on the principle of precaution.

The obligation for registration exists only for “particularly worrying substances” (Registration, evaluation and permission of chemicals).

The current European Union legislation for chemical authorisations is a patchwork of many guidelines and adjustments. There are different rules for “existing materials” (on the market before September 1981) and “new substances”. While new substances must be tested extensively before receiving market authorisation, there are currently no such regula tions for old substances. A draft for the reorganization of chemical authorisations was adopted in October 2003 at a European level in order to standardise these authorisations processes.

 

Who does REACH concern?

REACH concerns manufacturers, importers and also users of chemicals. In the main manufacturers or importers of substances will become responsible for their registration.

In some cases however, companies who purchase substances in the European market (called downstream users) may have responsibility for registration.

Downstream users could be obliged to register, if they also synthesize or import alternative substances or preparations not already covered. Otherwise the user must examine whether his individual use of the substances is already considered in the material safety report of the manufacturer. If this is not the case, he can either request that the manufacturer note this use in the material safety report or he can provide a material safety report for himself.

The regulation means that anyone in Europe producing or importing a substance in an amount of > 1 t per year must register this material. Without registration further use or sale of the substance is forbidden.

Together with the registration, a technical dossier and (for uses over 10 t p.a.) a material safety report (CSR) has to be submitted, which takes into account the “identified uses“ of which the manufacturer has knowledge.

REACH authorization

For some substances there are registration exceptions. Particularly worrying substances have to be given authori zation under REACH legislation and their use can be subjected to restrictions.

This applies to:

  • CMR substances
    - substances, which fulfil the criteria of being carcinogenic.
    - substances, which fulfil the criteria of causing possible genetic effects.
    - substances, which fulfil the criteria of being harmful to the reproductive system.

  • PBT substances
    - substances, which are according to annex XIII persistent, bioaccumulatable and toxic.

  • VPvB substances
    - substances, which are according to annex XIII very persistent and very bioaccumulatable.

 

Substances with special, e.g. endocrinal characteristics which prove to have, after scientific evaluation possible serious effects on human health and the environment and therefore carry similar risks to the he groups of substances specified above.  In order to be able to accomplish registration, a multi level concept with different deadlines is intended.
 

Implementation of REACH

The REACH-regulations have been effective since June 1st, 2007 and begin with a notice period (12 months).

Until the REACH regulations come into full effect the previous regulations for registration will apply according to chemical law, i.e. during the 12 months notice period.  

For you as a potential nominator, however, it will be important during this period to prepare an exact overview of the chemical substances you have to deal with: what kind and quantity of substances you manufacture?

  • what kind of substances you buy within the European Union and
  • will the suppliers of these substances continue to produce or import?
  • what kind of substances you buy in countries outside of the European Union and
  • will these suppliers register their substances under REACH or
  • will you become responsible yourself for this registration?

At the end of this notice period you should be certain, what kind of substances you have to pre-register, because the pre-registration phase begins immediately thereafter.

June 1st, 2008 (6 months) (the pre-registration phase begins). Pre-registration means that you have to announce to the agency in Helsinki the names of all substances to be registered with suitable tags e.g. the CAS number, your address and/or name and address of a selected person, who will represent you in relation to the agency and the intended period of the registration. Finally the volume in which you bring these materials into circulation should be notified. If you want to make reference in the full registration procedure to test reports of similar substances, you must indicate also these substances at this time.

December 1st, 2008 (the end of the pre-registration phase).

Eighteen months after the entry into force of REACH, thus 6 months after beginning of the pre-registration you should have pre-registered all substances, for which you carry the responsibility of registration. Within the next month the agency will publish on the Internet a list of those substances, which have been pre-registered. 

January 1st, 2009 (beginning of information exchange).

One of the goals of pre-registration is, that manufacturers or importers of identical substances may come together in order to exchange and share certain information. This
should happen in an SIEF, an information exchange forum, which is formed for each substance, for which there exists more than one potential nominator.

This means that after pre-registration obligations have been met you should contact other manufacturers and importers, in order to prepare the exchange of existing data (in particular those concerning vertebrate animal effects).

 

What you need to do

1. Determination of your REACH-liabilities by evaluation

  • Do I manufacture substances?
  • Do I import substances or preparations?
  • Do I purchase alternatives?
  • Am I a downstream user?

 

2. What does my supplier make?

  • Will he register the necessary substances?
  • Are there existing alternatives to the substances?
  • Is my use of the substances listed in the material safety data sheet?

 

3. CTP GmbH Statement to Substances of Very High Concern (SVHC):

CTP GmbH, Ruesselsheim as responsible producer with reliable and long-term partnership  to our customers   keeps the  SVHC-listings under continuous review. Any new information related to further substances in question will be discussed internally  and the appropriate action taken  in order to avoid inconveniencies or production stops for our customers. We can assure you that any by CTP GmbH delivered product to your company does not contain substances listed in the SVHC-listing of ECHA (16.02.2009).

 

How do I evaluate my REACH responsibilities?

For example due to the creation of a „substances inventory“.

For every substance (a preparation, own products) the substances inventory should contain the following positions:

  • CAS-no.
  • EINCES-no.
  • ELINCS-no.
  • NLP-no.
  • hazard declaration
  • supplier (within/outside European Union)
  • registration by the supplier ( yes/no)
  • usage registration by supplier
  • own actions

 

Links about REACH