Risk Management of Industrial Chemicals in the EU
REACH, Registration, Evaluation, Authorisation and Restriction of Chemical substances, is the European Union (EU) chemicals policy that became effective throughout the EU in June 2007. REACH obligations commenced on June 1, 2008. Substances of Very High Concern (SVHC) that are included in Annex XIV of the REACH Regulation will require authorisation to ensure that the risks for the use of these substances are progressively controlled and replaced by suitable alternatives or technologies, where these are economically and technically viable.
The final deadline for the registration of phase-in (existing chemical) substances under the EU’s REACH scheme has now passed, and currently, the European Chemicals Agency (ECHA) is focused on assessing which substances pose an unacceptable risk to human health or the environment and what risk management measures need to be applied. ECHA refers to this process as “mapping the chemical universe”. Risk management measures may be imposed on substances or groups of substances and can have a significant impact on manufacturers, importers, and downstream users, and they apply regardless of tonnage. They include:
- REACH Authorisations
- REACH Restrictions
- Specific REACH measures for substances of very high concern (SVHCs)
- Measures for persistent organic pollutants (POPs).
SVHCs are defined as follows:
- Carcinogenic, Mutagenic or toxic for Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC. This directive has been replaced by Regulation 1272/2008, the so-called CLP Regulation. According to the CLP Regulation, these substances are categorised as 1a or 1b.
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation.
- Identified on a case-by-case basis as causing probably serious effects to human health or the environment of an equivalent level of concern as CMR, PBT, and vPvB substances.
Once a substance has been included in Annex XIV, it will be allocated a date from when the use or placing of the substance on the market will be prohibited unless an authorisation is granted (the "sunset date"). The substance will also be allocated a date at least 18 months before the sunset date by which an application for authorisation must be received if the applicant wishes to use or place the substance on the market after the sunset date. Substances on Annex XIV cannot be used or placed on the market after this sunset date unless an authorisation has been granted for that use or an authorisation application has been submitted to ECHA but no decision has yet been reached.
Applications for authorisation can be submitted by manufacturer(s), importer(s), and downstream user(s) of the substance, and one or several of these can submit an application for the same substance for one or more uses. Applications can also be made for groups of substances for one or more uses.
Application requirements include information on substance identity, details for uses for which authorisation is being sought, a Chemical Safety Report (either a new report if not already submitted as part of registration or an updated version providing significantly more detailed information on uses and risk management measures), an analysis of alternatives, and a substitution plan (where the analysis of alternatives shows that suitable chemical or technological alternatives are available). Socio-economic analysis may also be included in the application along with justifications for not considering the risk to human health and the environment arising from emissions and discharges.
How Can Exponent Help You With Your Authorisation Application?
With 30 offices and over 1,000 staff worldwide, Exponent is one of the largest scientific and regulatory consulting firms in the world and a leading provider of services to the chemical industry. From our offices in Europe, the U.S., and Asia, we offer a wide range of technical and regulatory expertise to help companies prepare their authorisation applications. Exponent’s large REACH team comprises regulatory affairs professionals, project managers, risk assessors, socio-economic analysts, and technical specialists in all scientific disciplines directly relevant to authorisation applications. Many of our consulting staff have been working in chemical regulation for over 20 years and have experience with the EU NONS scheme, the U.S. and OECD/ICCA HPV programmes, and global chemical registrations. Members of Exponent’s staff have been following REACH since its inception, were involved in the consultation process to help shape the legislation in its final form, and contributed to the scientific and regulatory content of the official guidance documents.
Exponent’s REACH team offers the following to clients:
- Experience—A company-wide REACH team with an in-depth understanding of the REACH Regulation and the latest developments to the guidance material. Our consultants have been working with REACH since its inception and have been involved in writing a number of the REACH guidance documents.
- Technical Expertise—Specialists in all areas relevant to authorisation under REACH, including toxicologists, ecotoxicologists, exposure specialists, economists, and regulatory affairs professionals, capable of producing all necessary regulatory documentation, Chemical Safety Reports, analysis of alternatives, and socio-economic analysis.
- Capacity—Significant in-house resources available to handle all aspects of the REACH authorisation process, including dedicated project managers to oversee the whole application production process.
- Geographic Presence—A major U.S. consultancy with experts in the UK and EU to ensure effective communication with ECHA.
Many of our scientists have worked in industry, with trade associations and consortia, as government regulators, or for contract research organisations, giving us unparalleled expertise with solving complex regulatory, scientific, and economic problems. Combined with the strong, diverse scientific and regulatory experience of our staff, this expertise gives Exponent the unique ability to offer you full and complete services to help you comply with your authorisation obligations under REACH.
The assistance we can provide includes:
- Pre-submission meetings – support the applicant at pre-submission meetings with ECHA including initial documentation preparation and responding to identified actions.
- Communication – with other potential applicants to determine their willingness to be involved to support their uses, as well as communication with other interested parties such as NGOs and government departments.
- Completion of application documentation.
- Acceptability of the Chemical Safety Report – review of the Chemical Safety Report to determine its suitability for authorisation and amendment of areas where further information or clarification is required.
- Analysis of alternatives – identification, with the applicant, of possible alternatives and an analysis of their suitability compared to the substance to be authorised. Production of suitable documentation of the analysis.
- Substitution plan – preparation of a suitable substitution plan to replace the substance to be authorised where the analysis of alternatives identifies this is possible.
- Socio-economic analysis – production of a suitable socio-economic analysis where it is determined that such an activity is necessary to support the authorisation application.
- Commenting periods – provision of comments on the draft opinions of ECHA’s committees for risk assessment and socio-economic analysis.
- Safety Data Sheet – update of the Safety Data Sheet following the completion of the authorisation application and providing downstream users with details of the authorisation.
- Full project management.
With offices and experts in the UK, EU, US, and Asia, we offer a comprehensive range of technical and regulatory expertise to help companies meet their REACH obligations.