REACH/Safe use of mixtures
In the European Union, chemical manufacturers are responsible for providing evidence of the environmental and health consequences of their proposed products to enable ECHA, the European Chemicals Agency, to evaluate the documentation and recommend approval or bans. The agency is responsible for reviewing substance documentation submitted by chemical companies.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the regulation adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry.
Brexit and the Adhesive and Sealant industry
FEICA has drafted a guidance document with practical information on trade post-Brexit, aiming to support adhesives and sealants companies in preparing for the potential effects of the United Kingdom leaving the European Union on 31 December 2020.
To improve the quality of the information on typical use and conditions of use of adhesives and sealants communicated in the supply chain, FEICA committed to the Chemical Safety Report/Exposure Scenarios Roadmap and developed Use Maps to support Chemical Safety Assessments under REACH that reflect relevant and realistic information on adhesives and sealants. FEICA Use Maps compile, in a harmonised and structured way, the majority of the industrial and professional applications of the adhesive and sealant sector. Registrants are urged to use the data contained therein to prepare or update their REACH dossiers.
- Download FEICA Use Maps (Version 2 - revised Oct. 2017)
- Download FEICA Use Map in CHESAR format (chr3)
- FEICA Use Maps - History of changes
The ‘Use Map package’ consists of four templates:
- the aforementioned use map template, which provides the general description of the uses;
- three separate templates providing the inputs needed to carry out exposure assessments, for workers (SWEDs), environment (SpERCs) and consumers (SCEDs). These specific templates for exposure assessments are provided below.
Sector-specific Workers Exposure Descriptions (SWEDs) and Safe Use of Mixtures Information (SUMIs)
SWEDs are meant to inform on operational conditions and risk management measures for activities by workers. Therefore, they can be used by registrants as inputs to their Chemical Safety Assessments. To help manufacturers and importers of substances to understand how substances are typically handled in the adhesives and sealants sector, FEICA developed SWEDs covering both industrial and professional applications.
- Download FEICA SWEDs (Version 2 - revised Oct. 2017)
- Download FEICA SUMIs (version 1 - December 2018)
Information on the Sector-specific approaches for deriving and communicating information for the safe-use of mixtures by workers is available in the Guidance on "Sector-specific approaches towards developing and communicating information for the safe use of mixtures".
A set of supporting slides explaining this sectorial "bottom-up” approach for deriving and communicating information for the safe-use of mixtures by workers are also available, in different languages, on the DUCC website under 'Guidance and Tools'.
This approach has two main elements:
- Safe Use of Mixtures Information (SUMIs), which aim to provide simplified and tailored information on the safe use of mixtures for end-users,
- Sector-Specific Workers Exposure Descriptions (SWEDs), which contain detailed information for the workers exposure assessment and are the basis of the SUMIs.
SUMI pictograms: The Downstream Users of Chemicals Co-ordination Group (DUCC) of which FEICA is a member, has developed free-to-use pictograms to be used with the SUMIs. A total of seven pictograms are available on the DUCC website under Publications (Guidance & Tools). Please read the DUCC Disclaimer and Terms and Conditions of Use before making use of the files.
Use of SUMIs: Please see DUCC communication "How to use SUMIs: operational framework".
Specific Environmental Release Categories (SPERCs)
In addition, FEICA has developed sector-specific SPERCs. These are one of the exposure assessment inputs contained in the above-mentioned use maps, aiming to support registrants to carry out the environmental part of the REACH Chemical Safety Assessment. The SPERCs allow the refinement of the environmental emission estimations, as they provide more realistic parameter values. The relevant SPERCs for the adhesive and sealant industry are documented in SPERC fact sheets (which include sector-specific parameters, risk management measures and operational conditions). The SPERC Factsheets provide information on conditions of use and the related releases to the environment in a downstream user sector.
More information on how to use the SPERCs can be found in the Cefic guidance (version 2 - October 2012) which provides information from various industry sectors, including adhesives and sealants.
The revised FEICA SPERCs Fact sheets (revised Oct. 2017 - Jan. 2018) and CHESAR files are available for download hereunder:
- Revised FEICA SPERCs fact sheets
- FEICA SPERCs in CHESAR format (chr3)
- FEICA Background Document - SPERCs for the INDUSTRIAL USE of adhesives and sealants
- FEICA & EFCC Background document - SPERCs for the formulation of adhesives, sealants and construction chemical products
- FEICA & EFCC Background document - SPERCs for the widespread use of adhesives, sealants and construction chemical products
NOTE 1: The second generation of SpERCs were reviewed in accordance with the work done under the Chemical Safety Report/Exposure Scenario Roadmap (area 2.4), and following up on the outcome of the ‘Best Practices Project’. As a result, a new harmonised SpERC Factsheet Template - with explanatory notes - was published by ECHA. To facilitate harmonization, the revised FEICA SpERC factsheets are made available on this latest template.
NOTE 2: Cleaning files have been published and are available on the use map library. These cleaning packages are to be used by the assessors who have imported in their Chesar the previous version of FEICA SPERC files. The cleaning files will obsolete non-relevant library items in the Chesar application. They need to be imported in Chesar box 6 ("SPERCs” tab and "Condition of use templates” tab respectively).
Specific Consumers Exposure Determinants (SCEDs)
SCEDs are sets of realistic exposure determinants that aim to facilitate the exposure assessment of different consumer products, and are included in area 2 of the Chemical safety report/Exposure scenario roadmap (area 2.5).
FEICA - together with the Downstream Users of Chemicals Co-ordination group (DUCC) and CONCAWE (oil industry) - participated in this work, and the first developments resulting from this activity are now available:
- Download the SCEDs Guidance providing assistance on how to use the SCEDs for exposure assessments.
- Download the SCEDs harmonised template to compile the SCED information.
More information about SCEDs can be found on the DUCC webpage Activities.
To assist companies with the Chemical Safety Assessments of adhesives and sealants consumer’s products, FEICA SCEDs are publicly available as supporting information on their typical conditions of use. The FEICA SCEDs are intended to represent realistic assumptions for consumer exposure assessments for these specific products.
At present, FEICA has developed SCEDs factsheets covering the following adhesive and sealant products: universal glues, glues for DIY-use, spray glues and joint sealants.
- Download the FEICA Guidance Paper on SCEDs, containing four FEICA SCED factsheets.
- Download the FEICA SCEDs survey and its Supporting Paper.
Information on the Use Maps packages are available on the FEICA Extranet and the ECHA use map webpage. Should you have any questions or feedback regarding the FEICA Use Maps, please contact firstname.lastname@example.org.
Polymers Requiring Registration (PRR)
FEICA supports the efforts of the European Commission to develop a comprehensive regulatory framework for the registration of polymers under the REACH Regulation that will help to protect human health and the environment, without losing the competitiveness and innovativeness of the European industry.
FEICA has asked the Commission to consider the particularities of the adhesive and sealant industry. Criteria to define polymers requiring registration should be clear, scientifically sound and globally harmonised. Exemptions and reduced registration requirements, in applicable cases, should be considered by the legislator. See FEICA’s comments on the Wood/PFA report regarding Polymers Requiring Registration.
Customising polymers may result in a huge number of new polymers to be potentially registered. Further information is available in FEICA's Position Paper on Manufacturers of low-volume customised polymers at the end of the supply chain. For practical examples that illustrate how polymers are customised to market requirements and how big the number of affected polymers could be, check here.