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Demands on Manufacturers / Importers
The REACh Regulation is aimed chiefly at chemical manufacturers and importers. As a result these groups have the most obligations to fulfil. In addition to their (pre-) registration obligation for substances - incl. obtaining all the necessary data and information for the authorisation process - they are also committed to providing information and registering substances, as well as being obliged to apply for authorisation in the case of substances of high concern.

Pre-Registration

As of 01.06.2008 manufacturers and importers of existing substances either being produced to the amount of ≥ 1 t/y or being imported into the EU have to pre-register these with the ECHA in Helsinki, under provision of the following information:

  • The identity of the substance
  • The name and address of the registrant
  • The scheduled authorisation date and quantities
  • The identity of the substance(s) according to Appendix 4 category 2

When the pre-registration period has lapsed those phase-in substances which have not yet been pre-registered may no longer be produced, placed on the market or used according to the „no data - no market“ principle.

A late pre-registration subsequent to the transition period is possible under certain conditions in cases where a phase-in substance is being produced for the first time with a tonnage of ≥ 1 t/y.

Registration

Manufacturers and importers have to register the following substances with the ECHA if they are being produced in quantities of ≥ 1 t/y or being imported from a non-EU state:

  • Substances on their own, substances in preparations and substances intended to be released from articles
  • Isolated intermediates
  • No-longer polymers
  • Monomers

For phase-in substances which have been pre-registered the transition period may be utilised. As of 01.06.2008 new substances which are either being produced or imported into the EU for the first time must be immediately registered. New substances which have already been registered in accordance with Directive 67/548/EEC are regarded as already having been registered.

Exceptions Not Requiring Registration:

  • Substances which are either being produced or imported in quantities < 1 t/y
  • Substances used for product and process orientated research and development (PPORD)
  • Substances contained in pesticides and biocides
  • Substances listed in Annex IV (natural substances such as sugar, oils etc.)
  • Substances listed in Annex V where registration is deemed inappropriate or unnecessary (e.g. minerals, ores, coal)
  • Polymers

A registration dossier has to be submitted during the registration process. The specific data and information contained therein is dependent on the quantities involved and danger level of the substance. In cases where the quantities amount to ≥ 10 t/y a chemical safety report has to submitted alongside the technical dossier. This may also need to be accompanied by a description of the risk and an exposure evaluation.

What

Condition

Contents

Technical dossier acc. to Art. 10 Letter a)

Substances produced or imported in quantities of
≥ 1 t/y

Details on

  • Identity of the manufacturer or importer
  • Identity of the substance
  • Information on the manufacture and usage of the substance
  • Classification and labelling
  • ...

Quantity-Dependent Information Requirements

Substances produced or imported in quantities of
≥ 1 t/y
  • Information on the physical and chemical, toxicological and ecotoxicological qualities acc. to Annex VII

Substances produced or imported in quantities of
≥ 10 t/y
  • Information on the physical and chemical, toxicological and ecotoxicological qualities acc. to Annex VII and VIII

Substances produced or imported in quantities of
≥ 100 t/y
  • Information on the physical and chemical, toxicological and ecotoxicological qualities acc. to Annex VII, VIII and IX

Substances produced or imported in quantities of
≥ 1000 t/y
  • Information on the physical and chemical, toxicological and ecotoxicological qualities acc. to Annex VII, VIII, IX and X

Chemical Safety Report acc. to Annex I of the REACh Regulation

Also required by substances produced or imported in quantities of ≥ 10 t/y
  • Evaluation of the risk to human health and the environment, the physical and chemical risk,
  • ...

Also required for hazardous substances or when these meet the PBT or vPvB criteria
  • Exposure evaluation incl. an exposure scenario and exposure estimation
  • Description of the risk

Based on this manufacturers and importers can form syndicates to carry out a joint registration of a substance. A leading registrant submits a registration dossier containing all the information related to the substance. All the remaining manufacturers/importers submit special dossiers containing details as to their identities and applications.

Information requirements

The manufacturers/importers are committed to communicating such information on their substances within the supply chain that puts the recipient of the substance in a position to implement risk minimising measures, thus avoiding endangering human health or the environment. A well-known tool for passing on this information is the safety data sheet (SDS) which had to be compiled in the past to comply with EU Directives 91/155/EEC and/or 1999/45/EC on hazardous substances and preparations.

The safety data sheet compilation requirement has been adopted in the REACh regulations. According to the REACh Regulation, safety data sheets in accordance with Annex II of the REACh Regulation not only have to be provided and made available to professional users in the case of dangerous chemicals but also for PBT and vPvB substances.

In future, the manufacturer and/or importer must include information on the identified applications as well as information pertaining to the (denied) authorisation and on any existing manufacturing and application restrictions in the safety data sheet. One major change is the inclusion of exposure scenarios and the description of the corresponding risk minimisation measures in the annex to the safety data sheet in cases where the manufacturer/importer is required to compile a chemical safety report.

Even where no safety data sheet is required, the safety-related information necessary for adopting suitable risk minimising measures still needs to be passed on. Additionally, details on any restrictions and - if applicable - on (failed) authorisations must be passed down through the whole supply chain.

Authorisation

In cases of substances of very high concern the manufacturer/importer has to apply for a licence for every intended application. This includes the following substances:

  • · CMR chemicals
  • · PBT substances
  • · vPvB substances