Recommendations to industry

CEFIC developed a guidance document on how spERCs should be developed. The revised version published in 2013 provides clarification on several aspects which were commented in the 2010-study as unclear or missing. However, there is still room for improvement, in

particular:

• Many spERCs lack a clear description of how the release factors and the operational conditions are actually linked. This may partly be due to the fact that the CEFIC

66 If the information in the registrants’ CSRs is evaluated in the context of a substance evaluation in order to identify if there is a community-wide concern, the evaluating Member State may, on a voluntary basis, do a more extensive or thorough checking and use the acquired information and experience to feed into discussions on the quality of chemical safety assessment.

guidance does not elaborate this issue in detail. A respective chapter should be included in the next revision of the guidance.

• The different approaches to derive release factors are illustrated in the current guidance with examples. This approach seems appropriate, although a general description of the respective methods would be useful, too. However, the examples provided in the annex are not of sufficient quality and are therefore no appropriate illustrations of how the spERC should be derived and documented. Furthermore, they are not all provided in the new CEFIC format.

The examples should illustrate best practice and include more explanation on the quality and sources of base data and their justification in factsheets.

• Remaining doublings of information should be removed from the guidance and inconsistencies in wording should be removed.

• The understanding of the release factor to waste is obviously unclear. A discussion on what is possible and useful regarding this release factor should be started and

coordinated by CEFIC, resulting in clarification in the guidance document.

• Explanation on methods to derive and check the substance specific efficiency of RMMs is missing. At least a link to the CEFIC RMM-library could be included. Respective guidance would be important to enable spERC developers and users to make better use of RMM information.

• The consequences of iterating a CSR by “adding” RMMs should be more explicit; i.e. that the added RMMs become obligatory and have to be communicated to DUs.

• There seem to be still different understandings in industry regarding the scaling of exposure assessments. In the context of spERCs, scaling of release factors and related conditions of use is regarded as not appropriate. This is because the values of the release factors and the conditions of use are closely related and form the core of a spERC.

Hence, scaling parameters should exclude the OCs (except the use amount). This should be clearly stated in the CEFIC guidance.

• It seems that some of the information provided in spERCs was extracted from standard phrases; these phrases are partly undefined (e.g. process optimized for (highly) efficient use of resources) and could lead to misunderstanding on e.g. the coverage of the spERC.

It should be recommended in the guidance to avoid undefined terms or to define them in the spERC factsheet. Furthermore, CEFIC should recommend that no undefined terms are used to develop new phrases and that the existing ones should be specified / revised.

10.4.2 Industry associations

Industry is responsible to demonstrate the safe use of their substances in the chemical safety report for substances registered in amounts above 10 t/a. Some industry associations decided to support the registrants in the assessment by developing spERCs. Based on the assessment of spERCs performed in this project, the following is recommended to the industry associations:

• Delete any spERCs from tables or overviews for which no factsheets are available as they are not in conformity with the documentation standards of safe use of REACH (CEPE⁶⁷)

• Improve the existing spERCs regarding the shortcomings outlined in this report as soon as possible.

• Meanwhile updating, clearly communicate to registrants how the on-going

improvement will impact on their assessment. Recommend that spERCs be carefully used in emission estimation.

1. Highlight that the level of documentation of release factors may need

improvement as well as the description of operational conditions and RMMs.

2. Ensure that the spERC information generated automatically with CHESAR in the CSR is consistent with the information reported in the spERC factsheet.

3. Motivate registrants to re-check and possibly update their registrations dossiers, if they have used spERCs of which the release factors are found questionable in this report.

• Invest more efforts in the development of spERCs and respective CHESAR files; this includes data generation and documentation as well as (further) discussions with ECHA and the Member States on the quality of spERCs.

• Develop best practice examples.

• Provide old spERC versions on the internet.

• Encourage sector associations to develop spERCs if not yet done.

10.4.3 Registrants

Registrants are recommended to

• Carefully check if the scope of the spERCs they apply in their chemical safety assessment cover their use and inquire information from the industry associations in case this is not fully clear,

• Assess if the release factors and justification provided in the spERC factsheet are complete and sufficiently transparent

If not, additional information should be provided, e.g. on the operational conditions, risk management measures and justification of release factors, if available. This

information should be submitted to the industry associations responsible for the spERC so they can be taken into account in future revisions.

• Continue discussions with downstream users to ensure that information they provide are appropriate and, if not so, modify the spERCs accordingly and provide feedback to the respective spERC developers.

67 The CEFIC spERCs overview table published in April 2010 is not available on the internet anymore.

10.4.4 Downstream users

Downstream users receiving information on the safe conditions of use with the safety data sheets of substances and mixtures they use, which may be extended by attached exposure scenarios, should continue thoroughly checking the implementation of the conditions of use, regardless of whether or not reference is made to a spERC. They could support industry

associations developing spERCs by providing them with information on their conditions of use in particular if respective spERC based exposure scenarios do not reflect them well.