SDS: An essential document for the safe handling of your chemicals
SDS: An essential document for the safe handling of your chemicals
jeudi 23 juin 2022
The Safety Data Sheet (SDS) of a product is a key part of hazard communication throughout the supply chain. Its content and format have evolved considerably over the past forty years, and drafting an SDS has become an increasingly complex exercise.
In the European Economic Area (EEA [1]), the procedures for drafting and supplying an SDS are governed by the REACH regulation (regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006) via its article 31 and its annex II.
The SDS includes the classification and labeling elements established according to the CLP regulation (regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008).
In addition, information on the PBT/vPvB status [2] or the presence of substances from the Candidate list [3], for example, is required in the SDS.
Thus, each modification of the REACH or CLP regulations can potentially have an impact on the compliance of the SDS and carrying out a regulatory watch is essential to keep its documentation up to date.
It is important to keep in mind that an SDS does not only deal with hazardous substances and mixtures. For the latter, the person responsible for placing the product on the market must provide an SDS, spontaneously, on the first delivery of the product. Subsequently, when new information that could affect the risk management measures or new information concerning the hazards becomes available, or when an authorization has been granted or refused, or a restriction imposed, the SDS must be updated without delay and a new version sent to all recipients of the product for the last twelve months. The revised version will bear the indication of the modifications made.
Some mixtures require the provision of an SDS on request of the recipient of the product. This is the case for mixtures not classified as dangerous according to CLP but which contain dangerous substances above certain thresholds, but also substances subject to a community occupational exposure limit value, from 1%. It is recommended to always indicate in the SDS of the mixture which substance triggers the requirement. The products concerned by this obligation must also mention on the label the additional danger phrase EUH210 "Safety data sheet available on request".
The content of the SDS is the responsibility of the marketer at each stage of the supply chain. In the event that the SDS is drawn up from information received from suppliers upstream of the chain, the responsibility for the accuracy of the information present on the SDS provided with the final product (including their translations) remains with the responsibility of the marketer . It should also be noted that the supplier must always add his contact details in section 1.3 of the SDS, even when he uses his own supplier's SDS without modifying the content.
The SDS must be written by a "competent" person. Although this term is not defined in the regulation, it seems understandable that the author must have sufficient knowledge to write the different sections of the SDS. This work can also be shared within a team, in which everyone will be responsible for drafting the section corresponding to his/her kills or practical experience. The drafting work can also be entrusted to an external consulting firm. In all cases, the writers must have received appropriate training, as well as keeping this knowledge up to date.
As the establishment and supply of SDSs are obligations under REACH, the different versions of the SDSs must be kept for a minimum period of 10 years. However, it may be appropriate to keep them longer, for liability issues (example: products presenting a chronic risk) or other legal requirements.
Pursuant to Article 31(8) of the REACH Regulation, "A safety data sheet shall be supplied free of charge in paper or electronic form no later than the date on which the substance or mixture is first supplied." However, the ECHA guidance (Guidance on the compilation of safety data sheets - Version 4.0) specifies that the obligation to provide must be understood as a proactive obligation for the supplier to actually provide the SDS rather than simply making it available passively, by example on a website. On the other hand, sending an e-mail with a direct and permanent link leading to the SDS of the product supplied would be acceptable.
If the SDS was provided with the first delivery of the product, there is no need to re-provide the SDS with subsequent deliveries to the same recipient unless the SDS has been updated.
It should also be noted that the SDS (and its appendices if the SDS is accompanied by exposure scenarios) must be provided in the official language(s) of the country in which the product is placed on the market.
As stated in the introduction to this article, the regulations are changing and carrying out a regulatory watch is essential to guarantee the compliance of the SDS drafted.
The last amendment to Annex II of the REACH Regulation was made by Regulation (EU) 2020/878, the application of which will become mandatory on 31 December 2022.
In this new text, the focus is on identifying substances in nanometric form, as well as substances with endocrine-disrupting properties. Additional information is now also required in section 3 for the SDS of mixtures (ATE, additional hazard statements, etc.), as well as in section 9 for the physico-chemical properties.
Completely writing an SDS remains a difficult exercise! Do not hesitate to consult the agenda of our training courses to help you in this achievement or to consult us for an outsourcing of the management of your SDS (drafting, regulatory monitoring, etc.).
You will also find interesting information on the page dedicated to SDS on the ECHA website: https://echa.europa.eu/en/safety-data-sheets.
[1] European Union, Norway, Iceland and Liechtenstein.
[2] PBT: persistent, bioaccumulative, toxic; vPvB: very persistent, very bioaccumulative.
[3] List of substances of very high concern candidate for authorisation.