- Welcome to Helsinki in May!
- Best practice in data sharing
- Evaluation Reports: Valuable advice to prepare for 2013
- Towards safer use of hazardous substances
- The first list of substances to be evaluated under REACH published: Increasing information for the safe use of substances
- Registrants are encouraged to re-examine their declared company size
- Examples of consumer articles containing SVHCs are now available
- Increased cooperation between the Enterprise Europe Network and ECHA
- New Chair of Committee for Socio-economic Analysis
- Results of the 25th Management Board meeting
- Luisa Consolini, Director of Information Systems: Staying focused
- A Member State's perspective: Substance evaluation is an open process
- Communicating good advice on chemicals to citizens: the Danish model
- Conference on REACH and CLP enforcement: Industry calls for uniform enforcement
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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
Evaluation Reports: Valuable advice to prepare for 2013
Companies which have to register substances by the next REACH deadline of 31 May 2013, are strongly advised to use the recommendations from the Evaluation report 2011 to ensure that their dossiers are compliant.
Evaluation (the "E" in REACH) assists industry in its obligation to provide adequate information on registered substances. The main findings of the evaluation process, which are reported by ECHA at the end of February every year, flag the most frequently found incompliances in the dossiers. ECHA's evaluation reports provide further recommendations on how to avoid these incompliances. This offers a unique opportunity for current and future registrants to take stock and act in line with the advice. Alongside previous editions, the Evaluation report 2011 is essential reading for registrants to achieve compliant and good quality registrations.
The main recommendations from the report of 2011 touch topics such as substance identity, chemical safety assessment and the use of read across. All such elements are essential for ensuring the safe use of chemicals while avoiding unnecessary testing on vertebrate animals.
1. Substance identity
Precise definition of the substance identity is the starting point and fundamental for the compliance of the registration dossier. The report shows that ECHA had to open more dossiers for compliance checks than initially planned because in about a quarter of the dossiers containing testing proposals, the substance identity was ambiguous and needed to be clarified by the registrant before the testing proposals could be examined.
When a substance is not well defined, this may not only signal that the dossier may cover more than one substance, but also undermines the pertinence of the hazard data, the risk assessment, the appropriateness of risk management measures and the extracted guidance on how to use the substance safely. Dossiers are routinely filtered and when the substance is not clearly identified, the likelihood of the dossier being selected for compliance check is higher.
- Define your substance precisely and unambiguously. The identity and composition specified in the registration dossier needs to be supported by appropriate analytical information on the substance manufactured and/or imported.
- Make sure that the substance identifiers and the test materials used in studies are representative for the registered substance.
2. Chemical safety assessment
The chemical safety assessment is crucial for the safe use of chemicals. Deficiencies have been observed in all parts of the chemical safety reports. If the assessment does not cover all the relevant hazards, uses and exposures, then some of the risks are not properly identified and remain uncontrolled. Consequently, the main aim of REACH, i.e. the safe use of chemicals, cannot be achieved.
- Be thorough in completing the chemical safety assessment.
- Classify the substance according to the CLP Regulation.
- Cover all identified hazards and uses with exposure scenarios.
- Demonstrate the safe use of your substances in the chemical safety report.
- Provide advice on the safe use of your substances and communicate it to your customers in complete safety data sheets.
3. Use of read across
Read across makes best use of existing data and can avoid unnecessary testing. However, this only holds true when the read across is scientifically justified and well documented. The registrant must ensure that the information needs are covered for all properties as they would be with the standard test data on the substance.
- Justify your read across approaches with sound reasoning, scientific evidence and available experimental data.
- Evaluation under REACH Progress Report 2011 and previous reports can be downloaded from ECHA's website.
- REACH 2013 web section
- ECHA support
Call for action!
The main finding of the report is that a large part of the examined registration dossiers raise concerns to different degrees and require ECHA to address the shortcomings by regulatory action. Of the 146 compliance checks completed in 2011, 134 resulted in ECHA requesting the registrant to provide further information. The most frequent shortcomings refer to substance identity (72%); mutagenicity (16%); exposure assessment and risk characterisation (9%) as well as robust study summaries (8%).
ECHA strongly encourages companies who have already registered, to read the recommendations of the report and proactively update their dossiers. New registrants can use it to prepare good quality and compliant dossiers.
Compliance is the registrants' responsibility
According to REACH, it is the responsibility of companies to ensure the safe use of their substances and compliance with the regulation. The evaluation process is there to support registrants to achieve compliance. Since 2011, ECHA offers the possibility of informal interaction to such registrants who received a draft decision requesting further information addressing detected incompliances in their dossiers. ECHA encourages registrants to use this opportunity, if they need clarification.
Text by Virginia Mercouri
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
Committee for Socio-Economic
18-22 March (tentative)
Management Board meeting:
Member State Committee:
13-17 May (tentative)