BC18: REACH and the Supply Chain Samantha Gordon ChemADVISOR, Inc
What is REACH? Registration, Evaluation, Authorisation, and Restriction of Chemicals Regulation (EC) 1907/2006 Adopted December 2006 Entered into Force June 1, 2007
What does REACH regulate? Registration Chemicals imported or manufactured in the European Union in quantities meeting or exceeding 1 metric ton per year per importer/manufacturer Deadlines and data requirements vary depending on tonnage and hazard characteristics Authorisation Substances of Very High Concern (SVHCs) listed in Annex XIV Restrictions Market restrictions
What else does REACH regulate? Supply chain communication Safety Data Sheets Substances in articles SVHCs listed on a candidate list to Annex XIV (candidates for Authorisation) Data sharing requirements Notification to Classification and Labelling Inventory
Exemptions Exempt from all REACH provisions Radioactive Substances Substances for purposes of national defense Substances under customs supervision Non-isolated intermediates Transport Waste
Exemptions Exempt from Registration Substances already registered in the EU, exported to a non-eu country and then reimported into the EU Substances listed in Annex IV Substances falling under the categories listed in Annex V Food and feed additives Medicines for human or veterinary Use Substances regarded as being registered Substances notified as new according to the DSD (ELINCS) Certain active substances in Plant Health Products Certain active substances in Biocides Exempt from Information in the Supply Chain In the final form intended for the final user Food and feed additives in food or feedstuffs Medicines for human or veterinary Use Cosmetics
Why is REACH so important? Everything is made from chemicals! Europe holds 28% of the chemicals industry No data, no market
Why is REACH so important? Cost is substantial Registration fees Micro Enterprises: 120-3.100 Small Enterprises: 480-12.400 Medium Enterprises: 840-21.700 Standard Fees: 1.200-31.000 Fees for confidentiality: 113-4.500 Updates: 113-19.500 Data requirements Authorisation fees Micro Enterprises: 7.500 + 1.500 /substance + 1.500 /use + 5.625 /additional applicant Small Enterprises: 25.000 + 5.000 /substance + 5.000 /use + 18.750/additional applicant Medium Enterprises: 40.000 + 8.000 /substance + 8.000 /use + 30.000/additional applicant Standard Fees: 50.000 + 10.000 /substance + 10.000/use + 37.500/additional applicant
Supply Chain Issues Two parts to the supply chain issue Determination of requirements/compliance Documentation
Getting back to the supply chain... Only EU-based legal entities may participate in REACH compliance EU Importers EU Manufacturers EU Only Representatives of non-eu entities The supply chain outside of the EU does not exist For substances imported into the EU, the importer is legally responsible, NOT the non-eu manufacturer or distributer or formulator.
Getting back to the supply chain... If you re not an EU entity, essentially this means: If you are sending a substance or a substance in a preparation (mixture) or an article to the EU, the EU-based importer bears the responsibility unless the non-eu entity has appointed an Only Representative to bear the responsibility for REACH compliance
Exporting One Ton or More of a Substance to the EU to One Legal Entity
Exporting One Ton or More of a Substance to the EU to Two Different Legal Entities The tonnage is split.
Exporting One Ton or More of a Substance to the EU to One Legal Entity from Two Different Members of the US Supply Chain The tonnage is aggregated.
Exporting One Ton or More of a Substance to the EU to Two Different Legal Entities from Two Different Members of the US Supply Chain The tonnage is split.
Substance is imported from the EU, formulated into a product and exported back to the EU The substance is already registered?
A More Complex Model Importer 5 and Importer 6 both register Monomer A. Why? While it is the same Monomer A from the same source and while it is connected in the global supply chain, there is no direct connection in the EU supply chain. Importer 5 does not register Monomer B. Why? Monomer B was already registered by Manufacturer 2 and after being incorporated into a product, it is re-imported. Picture: Guidance for Monomers and Polymers, ECHA, 2008
What Does Registration Entail? Preregistration or Duty to Inquire Building Registration Dossiers Sharing of Test Data Substance Information Exchange Fora (SIEF) Joint Registration of Dossiers
What Does Registration Entail? Data Requirements Physicochemical Toxicological Ecotoxicological
What Does Registration Entail? Phase-In Substances Listed on EINECS Manufactured in the EC in the 15 years prior to entry into force Notified as new under the DSD but not a polymer Non-Phase-In Substances Everything else
What Does Registration Entail? Phase-In Substances Preregistration No market disruption Phased implementation schedule For Registration tonnage is considered as an average per year over the course of three years Non-Phase-In Substances Duty to Inquire No Phase-In Schedule Must cease all manufacture/import until registration is considered complete (3 weeks following submission of dossier) For Registration, tonnage is considered for the calendar year of Registration
What Does Registration Entail? Picture: Guidance for Registration, ECHA, 2007
Communication in the Supply Chain Safety Data Sheets Information required when an SDS is not required Substances in Articles Each member of the [EU] supply chain must communicate one member up and one member down
Communication in the Supply Chain Important implications of REACH compliance in terms of the SDS Identified Uses and Uses Advised Against Registration number Derived No-Effect Levels (DNELs) and Predicted No-Effect Concentrations (PNECs)
Getting Ready Get prepared! Get into the details before you identify a strategy The cost is in the technical work Tighten up internal communication When a substance is sourced differently it can have major implications on REACH requirements!
Getting Ready Open up communication between yourself and your customers and your suppliers, even those not based within the EU Is my customer planning on registering this anyway? Does my supplier have an OR and should we use that same OR? Has it been shown that the substance was originally sourced in Europe?
Getting Ready Keep in mind the following: Decisions need to be made on a substance-bysubstance basis The supply chain outside of the EU does not exist therefore you are NOT automatically covered if your non-eu supplier preregisters/registers. Also, be careful where conflicts may arise with competition law