BC18: REACH and the Supply Chain

Samantha GordonChemADVISOR, 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 LabellingInventory

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 re-imported 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

• Everything elseNon-Phase-In Substances

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

• 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

Non-Phase-In Substances

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-by-

substance 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