Questions you may get from your EU customers, and Questions you should be asking your EU suppliers Case Study – Non-EU Formulator Jarlath Hynes

Supply Chain Communication?

Re-Import exemptions To benefit from this exemption, you need to document that the following conditions are fulfilled: The substance must have been registered before it was exported from the EU. The substance must be the same as the substance being re-imported. The substance must come from the same supply chain in which the substance was registered. The re-importer must have been provided with information on the exported substance as required by REACH e.g. (extended) Safety Data sheet.

Key Questions for suppliers Substances are registered? If you are the registrant, provide registration number OR letter of compliance and eSDS. If you are re-importing under exemption, provide documentary evidence. If you are claiming exemption from registration (e.g. Annex V), provide documentary evidence / statement of compliance. Are my customers’ uses covered? Relevant for substances registered >10 tpa To be reported in the eSDS – Operational Conditions (OC), Risk Management Measures (RMM) If uses are not covered, or ‘Advised against’: Ask supplier to include or, Self-reporting by your EU customer under REACH Articles 37 and 38.

Safety Data Sheets (SDS) Safety Data Sheets are the key tool of downstream communication in REACH. Ask your supplier to provide REACH-compliant SDS and exposure scenarios. In a Substance SDS, Section 1.1 contains: • The REACH registration number (format 01-xxxxxx-xx-xxxx) • The substance uses and uses ‘Advised against’ If the product is a mixture, the registration numbers of the substances present in the mixture must be declared in Section 3.2. SDS are not required for the general public Sufficient information for safe use must be provided when an SDS is not provided If a substance or mixture is sold to both downstream users and general public, SDS need not be supplied, unless requested by downstream user or distributor

Exposure Scenarios (ES) A Chemical Safety Assessment (CSA) is carried out to demonstrate that the risks from the reported uses of a substance are controlled under specified ‘Operational Conditions’ (OC) and ‘Risk Management Measures’ (RMM). These ‘conditions of use’ of a substance constitute the exposure scenarios, which are reported in the Chemical Safety Report (CSR). Typically, downstream users do not receive a copy of the CSR. Instead, Exposure scenarios are included as an annex to the safety data sheet for substances. Ask your supplier to provide REACH-compliant SDS and exposure scenarios. For formulated mixtures, the supplier must consolidate and communicate the information from exposure scenarios for the individual ingredient substances. Responsibility? Who is ‘placing on the EU market’

Extended Safety Data Sheets (eSDS) The main information relating to risk management is in Sections 7, 8 and 9 of the SDS and in Section 3 of the ES. Your customer’s use should be included and your conditions of use should match those in the exposure scenario from your supplier. Otherwise, contact or change your supplier to have your use covered, or: Customer may need to report downstream uses according to REACH Articles 37 & 38. This may require preparation of a new Chemical Safety Report! https://echa.europa.eu/regulations/reach/downstream-users Be aware of special requirements for SVHC and substances requiring authorisation!

Key Questions from EU customers • Substances registered? • Registration numbers / Exemption Justification / Compliance Statement • Substance / Mixture correctly classified (harmonised), labelled and packaged? • Poison Control Information? • Uses covered and detailed in eSDS? • Recommended Operational Conditions (OC) and Risk Management Measures (RMMs)? • Documents available in local language?