REACH Regulatory Services
We can advise and assist in all areas of REACH and are able to help companies to fulfil their REACH obligations and to continue manufacturing and selling chemicals on the EU market. This includes assisting with consortium formation, assessing data requirements and availability, data evaluation, data valuation and dossier production in IUCLID 5. We can also undertake exposure evaluations, risk assessments and produce the CSR for substances manufactured or imported in quantities of 10 tonnes per annum and above. You can be confident that JSC will provide the highest level of expertise and service to ensure that you meet the requirements of this complex new legislation.
REACH (the Registration, Evaluation, Authorisation and restriction of Chemicals) is the most significant piece of legislation to affect the chemicals industry (Regulation (EC) No 1907/2006) and concerns all chemical substances, be they stand-alone substances, substances within preparations or substances in articles. It came into force on 01 June 2007 and replaces a number of European Directives and Regulations with a single system. Under REACH, unless exemptions apply, companies that manufacture or import more than one tonne of a chemical substance per year will be required to register them with ECHA, the European Chemicals Agency. The aims of REACH are to improve the protection of human health and the environment, whilst simultaneously maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industryRegistration requires the submission of a Registration Dossier and, for substances imported in quantities of 10 tonnes or more per year, a full risk assessment in the form of a Chemical Safety Report (CSR).
The REACH technical dossier will require the submission of a range of data. The data requirements are based upon volumes and are banded (1-10, 10-100, 100-1000 and >1000 tonnes) with the higher volume chemicals requiring more data. The data requirements are arranged within Annexes VII, VIII, IX and X of REACH, respectively.
1 December 2010
- > 1000 tonnes/year
- > 100 tonnes/year and R50/53
- > 1 tonne/year and CMR Category 1 or 2
1 June 2013
- > 100 tonnes/year
1 June 2018
- > 1 tonne/year
Late pre-registration is possible for companies importing phase-in substances into the EU for the first time in quantities of 1 tonne or more for the first time after 1 December 2008. The first-time manufacturer/importer must pre-register (1) at the latest six month after its manufacturing, or import exceeds the one-tonne threshold, and (2) at least 12 months before the relevant deadline for registration.
In the second stage of REACH, companies who have pre-registered the same substances will need to work together to produce the registration dossier. This will be achieved through the formation of a Substance Information Exchange Forum (SIEF).
Inside the consortia companies will share and assess data and prepare common parts of the registration (joint submission). Any SIEF member receiving a request for information that involves vertebrate tests must respond within 1 month. Compensation for sharing data is agreed among the respective SIEF members. If data are not available companies may have to undertake new tests on their chemicals or submit a test proposal to ECHA (Annex IX and X data requirements).
Certain substances of very high concern will require authorisation for use. These substances will include CMRs in category 1 and 2, persistent, bioaccumulative and toxic chemicals (PBTs) or very persistent and very bio-accumulative chemicals (vPvBs), together with substances identified as causing serious and irreversible effects to humans or the environment, such as endocrine disruptors.
