International Regulatory Support:
Europe - REACH

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) Regulation came into effect in June 2007 to streamline and improve the legislative framework for chemicals in the European Union (EU). REACH also established the European Chemicals Agency (ECHA) to manage chemical substance obligations under REACH and to ensure compliance among Member States. Beginning in June 2008, it became mandatory to register all new substances produced or imported in quantities greater than 1 tonne (2,204.62 pounds) per year. The pre-registration stage for existing substances was completed on Dec. 1, 2008. The first registration deadline ended in Dec. 2010, and included substances of very high concern (SVHC) and those manufactured or imported above 1000 tonnes per year. The upcoming registration deadline is in 2018.
The key stages of REACH involve:

▲ Pre-registration: “Phase-in” stage for existing substances (completed Dec. 1,  2008);

▲ Registration: Submission of dossiers by specific deadlines depending on annual tonnage
and on certain hazardous properties of the substances;

▲ Evaluation: Assessment of the substances by ECHA and the Member States’ competent

▲ Authorization: Substances of very high concern (including CMRs, PBTs, VpvB*) will be
authorized for specific uses and under specific conditions for given time periods; and

▲ Restriction: Regulation of substances as far as their manufacturing, marketing or use
conditions are concerned.

REACH has had a major impact worldwide on industries that manufacture or import chemicals, preparations and articles in or to the EU. In fact, REACH applies to all substances with only a few exemptions. Those exceptions include radioactive chemical producing plant regulated under REACH regulationsubstances, non-isolated intermediates, and substances being transported or monitored by customs. While REACH includes all other substances, some chemical products, such as pharmaceuticals, biocides and pesticides, are partially exempt from certain provisions of the Regulation.**

The obligations placed on chemical and associated industries to comply with REACH require regulatory specialists and scientific support. TSG, through our European extension, TSGE, has been involved with REACH since its inception. With regulatory specialists and scientific experts in human health, ecotoxicology, chemistry (analytical, physical and environmental) and risk assessment, TSGE is at the forefront of REACH compliance.

TSGE has led companies through every aspect of their REACH obligations since the legislation came into force, including technical dossiers and chemical safety reports for registration dossiers. In addition to providing guidance to companies and assessing the impact of their actions on business, TSGE offers the following:

Dossier preparation and specialized scientific support: TSGE’s specialists are highly experienced in data collation and retrieval, completeness checks, International Uniform Chemical Information Database (IUCLID) dossiers, chemical safety reports (CSR), extended safety data sheets (eSDSs), waivers, data valuation, proposing/commissioning of new studies, data archival, classification and labeling (C&L) and the assessment of SVHC.

Consortia management and support: TSGE offers managerial, secretarial and logistical support to consortia. With technical, financial and management expertise, TSGE assists manufacturers or importers in compiling and reporting total tonnage data while keeping an individual company’s product volume confidential. TSGE also helps determine data requirements based on quantity of substances reported and their intended uses.

TSGE is experienced in representing companies in Substance Information Exchange Forums (SIEFs). SIEF is a platform for data sharing formed by companies that intend TSGE consultants training clients on REACH complianceto register the same substance. SIEFs are established to facilitate information sharing, avoid study duplication and C&L Agreement.

Other services: In addition to offering training for industry in the form of workshops, seminars and presentations, TSGE offers an Only Representative service to companies outside the EU. This service includes many of the tasks listed above in addition to obligations of record keeping on tonnages, customers and their uses and the transmission of accurate, version-controlled safety data sheets.

As an independent consultancy, TSGE is also able to act as a Third Party Representative in situations where a registrant wishes to remain anonymous.

* CMR (Carcinogenic, Mutagenic and Reproductive), PBT (Persistent,
   Bioaccumulative and Toxic ) and vPvB (very Persistent and very Bioaccumulative)

** Please contact TSGE for up-to-date, detailed information on all exemptions or
    special rules applying to REACH Regulation
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