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The Revision of Annex II of REACH Regulation specifies in point 0.2.3 that:
“[…] The safety data sheet shall be prepared by a competent person who shall take into account the specific needs and knowledge of the user audience, as far as they are known. Suppliers of substances and mixtures shall ensure that such competent persons have received appropriate training, including refresher training.”
The term of “competent person” in this context as meaning a person (or combination of persons) – or a coordinator of a group of people – who has or have, as a result of their training, experience and continued education, sufficient knowledge for the compilation of the respective sections of the SDS or of the entire SDS.
The supplier of the SDS can delegate this function to his own staff or to third parties. It is not necessary that the expert knowledge be provided in full by one single competent person.
It is understood that a single person very rarely has extensive knowledge in all the fields covered by an SDS. It is thus necessary that the competent person rely upon additional competences, either internal or external.
The competent person should ensure the consistency of the SDS, especially if he acts as the coordinator of a group of people.
There is a specific duty on the supplier of the substances and mixtures to ensure that the competent persons have received appropriate training and refresher training.
There is no specific indication in the REACH Regulation of the training which the competent person should have or that he should attend a special course or pass an official examination. However attendance at such courses and any examination and certification may be useful in demonstrating the required competence.
Training and continued education for these persons may be given internally or externally.
It is recommended to document the organizational flow in the compilation and update of SDSs within a company, e.g. by way of internal guidelines or operating procedures.
If SDSs are to be compiled for explosives, biocides, plant protection products, or surfactants additional knowledge on specific products legislation applicable to them is needed.
The text of point 0.2.5 of Annex II to REACH specifies that:
“The date of compilation of the safety data sheet shall be given on the first page.
When a safety data sheet has been revised and the new, revised version is provided to recipients, the changes shall be brought to the attention of the recipient in Section 16 of the safety data sheet, unless they have been indicated elsewhere.
For the revised safety data sheets, the date of compilation identified as “Revision: (date)” as well as a version number, revision number, supersedes date or other indication of what version is replaced shall appear on the first page”.
Thus, revisions must be identified as such on the first page and information on the changes must be given either in section 16 or elsewhere in the SDS.
SDS format and content are defined by Article 31 and Annex II of REACH Regulation. The latest change is from 1.6.2015 by Regulation No. 830/2015/EC and safety data sheets issued before 1.6.2015 must be in compliance till 31.5.2017 as a latest.
Classification in the safety data sheets is in compliance with CLP Regulation No. 1272/2008/ES from 1.6.2015. For the cases where mixture was classified labelled and entered the market before that date, then exemption to re-clasify is valid till 1st of June 2017.
Other reason for the SDS revision is CLP Regulation up-date (ATE) No. 918/2016/EC from 19.5.2016, were e.g. some hazard phrases are changed (H). This regulation has to be followed from 1.2.2018 as a latest.
- Safety Data Sheet – Definition
- Why is SDS needed?
- For which substance or mixture?
- Format of safety data sheet
- Update of safety data sheet
- Labels design
- How will CLP affect the SDS?
- Content of safety data sheet
- The content of an SDS – Responsibility
- Who should compile an safety data sheet (SDS)
- SDS and label