EKOTOX CENTERS has a specialized focus on crafting safety data sheets, tailoring them to meet the precise demands outlined by the CLP and REACH Regulations, alongside any supplementary prerequisites stipulated by EU member states. These crucial documents necessitate the expertise of a skilled professional endowed with the right knowledge and training. It’s imperative to consider the distinct provisions of each corresponding EU member state. This encompasses factors such as languages, occupational limit values, notification to national toxicological centers, and an array of other essential elements.
But, be careful, just „translation” of a safety data sheet document drawn up by an ordinary translator who has no knowledge of chemicals legislation could not be in compliance due to specific legal terms so it is often drawn up by translations that are too literal, erroneous and not in accordance with the European guidelines for drawing up safety data sheets. More to that, safety data sheet is today more complex and so multidisciplinary team will definitely be of an advantage.
Our specialists have many years of experience and daily working on different aspects of EU chemicals legislation, including: classification of chemical substances and mixtures, assigning H and P phrases, rules of labelling and packaging of substances and mixtures, notifications in the Poison Centre, assigning UFI codes, advising in labelling, managing the safety of documentation.
Language(s) in which the SDS must be provided:
In accordance with REACH Article 31(5), the safety data sheet must be provided in the official language of the Member State(s) where the substance or mixture is being marketed, unless other provisions are made by the concerned Member State(s).
It is important to highlight that the responsibility for making such provisions lies with the recipient Member State (MS). To clarify, an exemption in the manufacturing MS does not automatically apply to a different MS where the substance or mixture is placed on the market. Even if the recipient MS sets different provisions, it might still be advisable to offer the safety data sheet in the language of the respective country.
Furthermore, it is worth noting that specific Member States necessitate the safety data sheet to be available in multiple official languages (of that particular MS) if the MS has more than one official language.
Additionally, it is crucial to recognize that the annexed exposure scenario is an integral component of the safety data sheet. Consequently, it is subject to the same translation prerequisites as the SDS itself. In other words, it must be provided in an official language of the Member State(s) where the substance or mixture is placed on the market, unless the recipient Member State(s) provide alternative guidelines.
SDS – New requirements 2022
Amendments and modifications to the REACH and CLP regulations are progressively ushering in heightened requirements pertaining to the format and substance of the Safety Data Sheet (SDS). Consequently, companies are obligated to strategically devise an implementation process, thereby guaranteeing adherence to the stipulated legislative prerequisites.
Each supplier of chemical mixtures must fulfil obligations under Article 31 of REACH (Requirements for safety data sheets) and Annex II of REACH regulation. The references to the legal text have been updated to reflect the latest version of Annex II (i.e. the Annex to Regulation (EU) 2020/878).
The Commission Regulation (EU) 2020/878 introduces changes in the scope of:
– new requirements for nanoforms of substances, adapting to the 6th and 7th revision of the GHS, and adding requirements regarding the Unique Formula Identifier (as set by Annex VIII to Regulation (EC) 1272/2008), endocrine disrupting properties, specific concentration limits, M-factors and acute toxicity estimates…
The document provides for changes in the provisions and the format of the safety data sheet. The most important changes include:
– new format for section 9
– separation of a new subsection 11.2
– separation of new subsections 12.6 and 12.7
– the wording of the subsection changed in sections 14.1 and 14.7.
Countries and languages of SDSs:
EKOTOX CENTERS offer SDS authoring for a wide range EU member states and other countries, basically in the following languages:
– Austria – German
– Belgium – French/German/Dutch
– Bulgaria – Bulgarian
– Croatia – Croatian
– Cyprus – Greek
– Czech Republic – Czech
– Denmark – Danish
– Estonia – Estonian
– Finland – Finnish
– France – French
– Germany – German
– Greece – Greek
– Hungary – Hungarian
– Iceland – Icelandic
– Italy – Italian
– Latvia – Latvian
– Lichtenstein – German
– Lithuania – Lithuanian
– Luxemburg – French
– Malta – English
– Netherlands – Dutch
– Norway – Norwegian
– Poland – Polish
– Portugal – Portuguese
– Romania – Romanian
– Slovakia – Slovak
– Slovenia – Slovenian
– Spain – Spanish
– Sweden – Swedish
– Switzerland – German/English/Italy/France
– United Kingdom and Ireland – English
– Ukraine – Ukrainian
If you have not found the appropriate country / language above, please contact us for an individual assessment of the possibility of preparing a required document.