SDS in different languages
Article 31(5) of the REACH regulations(1) states
The SDS shall be supplied in an official language of the Member State(s) where the substance of preparation is placed on the market, unless the Member State(s) concerned provide otherwise.
This means that the Member State may give authorisation to an alternative to their national language(s). However, even if the Member State says otherwise, it may be desirable to always provide the SDS in the native language of the country.
Where the substance is placed on the market is critical to what language the SDS needs to be supplied in. For example, if a company in France finds a substance from a UK company website and wishes to buy the product, then the SDS only needs to be supplied in English, as it isn't aimed at the French market. If however, the substance is marketed in France then the SDS must be supplied in French.
The recently published European Chemicals Agency (ECHA) guidance(3) also notes that ˜the existence of an exemption in the Member State of manufacture does not give an exemption in a different Member State where the substance or mixture is placed on the market". Meaning that if a substance is manufactured in Ireland then the SDS may be written in English, but if marketed in Germany then the SDS still has to be provided in German, regardless of the language exemption.
Certain Member States require that SDSs be provided in multiple languages if more than one official language exists. 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.
In practice, this simply means if you ship a product aboard you will need to ensure you provide the SDS in the national language(s) of that country, unless the language is exempt. For help with this NCEC's global SDS Authoring and compliance consultancy services offer a comprehensive solution to meet the requirements of all regional and national legislation.
Emergency telephone number
Sub-section 1.4 of Annex II(2) refers to the use of an emergency telephone number.
˜References to emergency information services shall be provided. If an official advisory body exists in the Member State where the substance or mixture is placed on the market (this may be the body responsible for receiving information relating to health referred to in Article 45 of Regulation (EC) No 1272/2008 and Article 17 of Directive 1999/45/EC), its telephone number shall be given and can suffice. If availability of such services is limited for any reasons, such as hours of operation, or if there are limits on specific types of information provided, this shall be clearly stated".
The above mentioned Articles 45 and 17 state that a Member State shall appoint a body responsible for receiving information including the chemical composition of mixtures classified as hazardous on the basis of health or physicochemical effects. Such information could be needed to formulate preventive and curative measures in a chemical emergency.
The ECHA guidance(3) notes that in some Member States, the official advisory body may be solely for medical personnel to contact. In such cases, the SDS should clearly state that the number is intended for use by medical professionals only. Otherwise (or in addition), reference must be made to an emergency service belonging to a supplier or to a competent third-party emergency provider (for example, NCEC's Carechem24). In all cases, irrespective of the number used, suppliers should contact the service provider to confirm its number can be given and to clarify if any conditions apply, prior to using it on SDSs.
Simply put, if an official advisory body is available then it must be used. If not, (or in addition), the emergency service may be provided by the supplier or a third party e.g. Carechem24. There may be several points to note about this. In many cases, the appointed advisory body is a toxicology information centre and, hence, advice may be limited to health effects. They may not be able to provide information on non-health emergencies such as fires or spillages. Some centres do not operate a 24/7 service or simply provide an answer machine message. Moreover, the guidance states that all emergency service providers need to be contacted prior to adding their number to the SDS. Although this isn't a registration process as such it is important to ensure the correct details are used on the SDS and that they have the SDS for use in an emergency. Placing substances on the market in many Member States may result in the onerous task of contacting the many different advisory bodies.
On the ECHA web page listing of national helpdesks, Member States have, on ECHA's invitation, voluntarily listed links to telephone number(s) of appropriate national emergency information services to be used in sub-section 1.4 of the SDS.
It is interesting to note that the UK does not provide such a number, listing only details about the REACH and Classification, Labelling and Packaging of Substances and Mixtures Regulation (CLP) helpdesk. Because of this, Carechem24 is a good solution to this ambiguity in the UK. The NCEC, with its highly acclaimed 24/7 emergency service, classifies as a ˜competent third-party emergency provider". Hence, the use of this service would fulfil compliance with regulation, while providing expert advice in the event of a chemical incident.
Many customers have raised the question of having to provide multiple emergency numbers on their SDSs. As the SDS should be written in the official language(s) of the Member State, then the corresponding emergency number(s) in that Member State must be added if one exists. If not, then the Carechem24 number could be used to achieve compliance. Even if an official body does exist, Carechem24 could provide your company with a service that goes beyond compliance by covering all aspects of emergency response.
Overall, to be compliant with current legislation, you should comply with the following:
If you are not able to do the above, then NCEC could offer you solutions to achieve regulatory compliance. Please contact us for further information.
1. Regulation (EC) No 1907/2006 concerning the Registration, Authorisation and Restriction of Chemicals (REACH), 2001.
2. Commission Regulation (EU) No 453/2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), May 2010.
3. ECHA; Guidance on the compilation of safety data sheets, Dec 2011.