EKOTOX CENTERS specializes in authoring of safety data sheets based on the requirements of the CLP and REACH Regulations + additional requirements of the EU member state. The documents must be drawn up by a competent person with appropriate knowledge and training, taking into account specific requirements of the respective EU Member State starting including languages, occupational limit values, national toxicological centre notification and more.
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:
According to REACH Article 31(5), “The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide otherwise”.
It should be noted that it is for the recipient Member State (MS) to provide otherwise – i.e. for example the existence of an exemption in the MS of manufacture does not give an exemption in a different MS where the substance or mixture is placed on the market. Even if the MS provides otherwise, it may be desirable to always provide (potentially in addition) the SDS in the language of the country.
It should be noted that certain Member States require that the SDS be provided in additional official MS languages (of that MS, where there is more than one official language).
It should also be noted that as the annexed exposure scenario is considered to be an integral part of the SDS it is subject to the same translation requirements as the SDS itself – i.e. it must be supplied 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) concerned provide otherwise.
SDS – New requirements 2022
Amendments and modifications to the REACH and CLP regulation are gradually introducing increased requirements for the format and content of the SDS. It requires companies to plan an implementation process to ensure compliance with legislative requirements.
SDS changes:
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 has been 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:
EU countries
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;
NON-EU countries
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.