Explanation of the REACH result for certain issues
ChemSec, 13 December 2006
Authorisation
Adequate Control for Threshold Substances
Substances of very high concern (SVHC) for which thresholds are identified
can go through authorisation under the ‘adequate control’ route
for authorisation. This will include CMRs and hormone disrupting chemicals.
So long as a company can prove adequate control of the substance, then the
authorisation MUST be given even if safer alternatives are available.
Example: phthalate DEHP (a reproductive toxin)
In 6 years, there will be a review about whether to exclude hormone disrupting
chemicals from the adequate control route.
Non-Threshold Substances and Persistent Substances
CMR- and equivalent concern Substances for which thresholds cannot be identified
will not be able to go through the ‘adequate control’ route.
The same applies to PBTs and vPvBs (e.g. chemicals with PCB like properties, some brominated flame retardants, perfluorochemicals).
These will be eligible for an authorisation first, if it is proven that
the social and economic advantages outweigh the risks, and second, if there
are no suitable alternatives available.
Under these two conditions, i.e. suitable alternatives are available, and
the social and economic advantages do not outweigh the risks, our interpretation
of the legal text is that the authorisation may be granted granted, but
could also be denied.
Substitution plans
A Substitution plan shall be submitted by the applicant for authorisation
when the applicant identifies a safer alternative. Even if the agency committee
identifies a suitable alternative via third party contributions, this information
does not have to be taken into account for the adequate control route, but
only at the review of the already granted authorisation. If no alternatives
have been identified, triggering a substitution plan, then a research and
development plan must be submitted with the application for authorisation.
Reviews
The time period of each authorisation will be set on a case-by-case basis,
so the timing of reviews is individual to each substance.
Access to Information
Consumers will only have access to information about chemicals of very high concern in articles upon request. The response period is limited to 45 working days. Downstream users (defined as recipients, which includes both a downstream user in the supply chain, and a distributor / retailer of articles) will obtain the same information automatically. A review of whether this obligation to provide information to both consumers and downstream users should be extended to other dangerous substances will take place after 12 years.
It is unclear how much information in the application the applicant will be able to keep as confidential, as it will depend on what the applicant requests to be kept confidential, and whether the Agency agrees to the request. This concerns primarily the trade name and the IUPAC nomenclature.
Unfortunately it was decided that a chemical safety report will only be required for substances produced in volumes above 10 tonnes, not for substances produced in volumes between1-10 tonnes. A report includes a chemical safety assessment covering workers, consumers and the environment, including relevant exposure scenarios with appropriate risk management measures.
Substances in Articles
If an article contains SVHC above 0,1% of the weight of the article the manufacturer/importer has to notify the agency. It is not clearly stated whether the 0.1% limit shall be applied to parts or to the whole article. If the 0,1% limit applies for the entire article consumers or the Chemical Agency will probably not receive any information on SVHC contents in imported articles such as toys, clothes, electronic equipment etc. According to practice from Restrictions, RoHS and ELV directives, these kinds of limits are applied to parts/materials/components.
Duty of Care
There is no legally binding obligation to exercise a duty of care for all chemicals that a company produces. The duty of care is relegated to a non-legally binding recital which mentions the collection and communication of available information.
Downloads
Download the REACH text (pdf, 1,7 MB)
Facts and controversial issues 2006 (ppt, 1,26MB)
Report:
Implications of
REACH for developing countries
(pdf, 1MB)
Les implications de REACH pour
les pays en développement
(pdf, 1,4MB)