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registration evaluation authorisation restriction
 

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The 4 Elements of REACh

01.06.2007

  • The REACh Regulation takes effect

01.06.2008

  • Pre-registration of the phase-in substances begins

  • Registration of new substances

01.12.2008

  • Pre-registration period for phase-in substances ends

01.12.2010

  • The transition period for CMR substances ≥ 1 t/y per M/I, substances which may cause adverse effects in the aquatic environment (R 50/53) ≥ 100 t/y per M/I; substances ≥ 1000 t/y per M/I ends

01.06.2013

  • The transition period for substances ≥ 100 t/y per M/I ends

01.06.2018

  • The transition period for substances ≥ 1 t/y per M/I ends

 

Evaluation

A registration dossier must be submitted upon registration. Just how comprehensive this registration dossier has to be depends on the amount of a substance and its danger level. The registration dossier should include information on the following points, to name but a few.

 

  • Manufacturer’s / importer’s identity

  • Intended usage

  • Classification and labelling

  • Summary of the studies carried out with regard to the substance’s characteristics

  • Testing proposals

  • Results of any external quality testing which has taken place

  • Guidelines for safe usage, if applicable

  • Chemical safety report, if applicable

 

This dossier is then evaluated by the ECHA with respect to compliance with official specifications. The submitted testing proposals are examined in particular detail.

 

Due to the large number of registration dossiers expected generally no evaluation of the substance itself takes place. Possible substance evaluations are focussed on those substances which give cause for alarm, including, for example, substances which may cause cancer or heritable genetic damage (so-called CMR substances). A substance evaluation can be expected in around 5% of the cases.

 

Such a substance evaluation may prove to be the starting point for an authorisation or restriction process. Possible results of such a process: A substance requires authorisation or production and/or application restrictions may be enforced.

Authorisation

Principle: All applications are forbidden except those which have been authorised.

 

Those substances giving particular cause for alarm (SVHC substances = substances of very high concern) also have to be authorised for a specific usage. These substances include:

 

  • Substances which are carcinogenic, mutagenic or toxic to reproduction (CMR substances)

  • Persistent, bioaccumulative and toxic substances (PBT substances, please refer to Annex XIII of the REACh Regulation for the respective definition)

  • Very persistent, very bioaccumulative substances (vPvB substances, please refer to Annex XIII of the REACh Regulation for the respective definition)

     

In future, Annex XIV of the REACh Regulation will contain a directory of those substances requiring a licence. The list is currently empty. The first substances are expected to be entered in mid 2009.

 

The authorisation must be applied for and is subject to time restrictions. The European Commission bases its decision on the ECHA’s statement with regard to authorising the substance. Authorisation of a specific substance can be denied if

 

  • the risk cannot be adequately controlled or

  • there are no socio-economic benefits.

The Consequences: Usage is forbidden. An alternative must be used!

Restriction

Principle: All applications are allowed except those which have been restricted

 

Production and application restrictions are already controlled in Germany by the Chemicals Prohibition Regulation and the Ordinance on Hazardous Substances. In addition, those substances subject to either production restrictions or market placement and application restrictions are listed in Annex XVII of the REACh Regulation. These substances have been extracted without change from Directive 76/769/EEC. This list is not final and can be added to should there be findings to prove that a substance represents an unaccountable risk to both human health and the environment.