REACH and Singapore manufacturers and exporters
Obligations towards REACH are only imposed on businesses in the EU. This largely depends on the role each business plays in the supply chain. It is important for Singapore manufacturers and exporters who may be part of this supply chain to understand these different roles and assess the potential impact of REACH on their businesses. The more you know about REACH, the more you can ensure that your goods can remain in the EU market.
The European Commission has developed technical guidance documents and navigator tools relating to REACH obligations.
1. Registration
It is estimated that 30,000 substances are expected to be registered over the first 11 years after REACH comes into force.
Registration requires submission of a registration dossier in the form of either :
- A technical dossier (for substances in quantities one tonne or more) with detailed information on the properties, use and classification of a substance, and guidance to safe use.
OR
- A chemical safety report (CSR) (for substances in quantities 10 tonnes or more) with safety assessment of the substance, demonstrating safe handling for all identified uses and manufacturing. Exposure scenarios will need to be described in the CSR.
ECHA will perform a completeness check and provide a registration number and registration date. It is the responsibility of the registrant to provide any updated information (e.g.: new uses, changes in composition, quantities, new classification and labelling etc.) to ECHA. Failure to register = No market
2. Evaluation
The European Chemicals Agency (ECHA) will coordinate two types of evaluation.
- Dossier evaluation
ECHA coordinates compliance checks and reviews the testing proposals submitted in the dossier. This allows regulatory authorities of EU member states to determine if further testing is needed and assess if information provided by the industry complies with the requirements.
- Substances evaluation
Substances suspected of posing a risk to health or the environment will be selected for evaluation. This may lead to restrictions or authorisation procedures.
Restrictions
The restriction procedure acts as a “safety net” which enables the EU to adopt a legislative ban/restriction on the use of substances--on its own, when present in preparations or in articles -- which present unacceptable risks to health or the environment. The EU’s current restrictions set out in Directive (76/769/EEC) have been consolidated into
Annex XVII of the REACH Regulation.
Authorisation
REACH requires substances of very high concern (SVHC) to undergo pre-market/manufacturing approval.
The following are SVHC :
- Carcinogens, mutagens, repro-toxicants (CMR) of category 1 and 2
- Persistent, bioaccumulative toxicants (PBTs) and vPvBs
- Other substances identified as causing serious effects on humans or the environment (e.g.: endocrine disruptors)
Authorisation of these chemicals will be based on adequate control risks, socio-economic advantages and availability of substitutes. The list of SCVC will be available on the ECHA’s website in late 2008. It is estimated that 1,500 SCVC will make it to this list.