SDS for export to the EU: which language, which country, 1.4 and 15.1

Is a Turkish GBF enough in the EU?

No. A Turkish GBF is prepared under Annex 2 of the KKDİK Regulation. On the EU market the basis of the SDS is Annex II of the REACH Regulation (EC) No 1907/2006, as amended by Regulation (EU) 2020/878, which describes today's 16-section form. The two structures are very similar but differ in places such as the heading reference, 1.4 and Section 15. So for a product going to the EU, you prepare a separate form under REACH Annex II instead of just translating the Turkish GBF. For classification and labelling the EU rule is the CLP Regulation (EC) No 1272/2008; its Turkish counterpart is the SEA Regulation.

Who must prepare and supply the SDS in the EU is a separate question: under REACH the obligation lies with the supplier placing the product on the EU market. A Turkish exporter should settle in the contract how this is split with its EU buyer, importer or responsible supplier. This article only covers the language of the form and two of its subsections.

Which language? Article 31(5)

Under REACH Article 31(5) the SDS is supplied in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State concerned provides otherwise. The rule is therefore not "the buyer's language" but the official language of the country where the product is placed on the market. If you sell the same product in Germany and in France, you need an SDS in two languages. The words "unless the Member State provides otherwise" matter too: whether a country has a different arrangement must be checked in that country's own legislation or with its competent authority.

In multilingual countries there is more than one official language. Chemoris maps countries to languages based on their constitutions and language laws:

In practice, which language or languages are required in these countries depends on the country's own rules and on your agreement with the buyer; Article 31(5) only says "official language". Chemoris has no Irish output; for Ireland you get an English document.

The label rule is similar: under CLP Article 17(2) the label is written in the official language(s) of the Member State(s) where the product is placed on the market, unless the Member State concerned provides otherwise.

1.4 Emergency telephone number

Under Annex II 1.4, if the Member State has an official advisory body (which may be the body that receives health-related information under CLP Article 45), its telephone number is given and is sufficient. If the service is limited in hours or scope (for example, only at certain times), this must be stated clearly. 1.4 is not harmonised in the EU: the number, preconditions and service language differ from country to country. Examples:

• Netherlands: the NVIC number is +31 (0)88 755 8000; the centre asks for the sentence that the number is only for informing medical personnel in case of acute intoxications.
• Belgium and Luxembourg: the Belgian Centre Antipoisons numbers (070 245 245; +352 8002 5500 for Luxembourg) may be written in 1.4 only after the mixture has been notified for the country through the ECHA PCN portal (CLP Annex VIII).
• Malta: the 1774 helpline is open 08:00–20:00, not 24 hours; this must be stated in 1.4.
• Germany: there is no official advisory body (TRGS 220, 4.1.1); you need a company number or the number of a contracted Giftinformationszentrum.
• Ireland: the NPIC number may be used only after the PCN notification and a paid agreement with NPIC are complete.
• Poland and Romania: no free official 1.4 number could be verified in a primary source; for these countries the company must give its own emergency number.

So a single international number is not a solution for every country. You either write the official body's number for the country (with its preconditions) or add a 24-hour number of your company or a contracted service that works in the relevant language.

15.1 National legislation

Annex II 15.1 is where safety, health and environmental legislation specific to the substance or mixture is stated; where relevant, national measures belong here next to EU legislation. The EU-level list is the same for all countries; the national line shows the national transposition texts of the target country's occupational health rules (Directive 98/24/EC, chemical agents) and major accident rules (Directive 2012/18/EU) and, where they exist, country-specific classifications (for example the water hazard class, WGK, in Germany). Which national text to cite therefore cannot be decided without knowing the target country. If a country's transposition record cannot be found in the sources, add the country's occupational health legislation to 15.1 manually.

What Chemoris does and does not do

• Language: in the EU profile, output in 24 languages (Turkish and the 23 official EU languages; no Irish). You select the target country (30 countries: the 27 EU Member States, Norway, Iceland and Liechtenstein); 1.4 and Section 15 are written for that country.
• Official text: H and P statements and section headings are the official EUR-Lex wording in each language. Other fixed texts come from a translation catalogue, so a native-language review before placing on the market is recommended. The output carries this warning.
• 1.4: where the country has an official number, it appears from the table together with its precondition warning. For Poland and Romania (and countries without an official body) the company enters the number; if it is empty, a warning is shown.
• Limits: Chemoris gives no legal assurance; it does not handle a Member State's language conditions, PCN notification or number contracts for you. Final checking and responsibility remain with the supplier issuing the SDS.

Short pre-shipment checklist

• Have the target countries and their official language(s) been listed? For multilingual countries, has the required language been confirmed?
• Is the form prepared with the REACH Annex II (Regulation (EU) 2020/878) heading reference and 16 sections?
• In 1.4, are the number valid for the country, service hours and preconditions (PCN notification, contract) in place?
• Does 15.1 contain both EU and national lines?
• Is the label in the same official language (CLP Article 17(2))?
• Has a native-language review been done for texts that come from the translation catalogue? This step also prevents some of the common GBF mistakes.

To see the sections of the form, read how to prepare a Turkish SDS; for the obligations on the Turkish side, see GBF under KKDİK.

Sources

• REACH, Regulation (EC) No 1907/2006, Article 31(5) (SDS language) — CELEX:02006R1907.
• Commission Regulation (EU) 2020/878, REACH Annex II (1.4 and 15.1) — CELEX:32020R0878.
• CLP, Regulation (EC) No 1272/2008, Article 17(2) (label language), Article 45 and Annex VIII — CELEX:02008R1272.
• ECHA, Guidance on the compilation of safety data sheets (echa.europa.eu) and ECHA's list of national advisory bodies.
• National sources: TRGS 220 (Germany) 4.1.1; pages of NVIC (Netherlands), Centre Antipoisons (Belgium), the Malta National Poisons Centre and NPIC (Ireland).
• Country-language mapping: constitutions and language laws of the countries concerned (itemised in the Chemoris rule files).