Importers‘ Obligationsunder REACH & CLP

Dr. Dieter DrohmannOnly Representative Organisation (ORO)

REACH & CLP Networking

Luxemburg, 8th December 2016

► ORO – The Only Representative Organisation

ORO’s main objectives are to: Set up OR quality standards

Develop a common understanding of REACH requirements for ORs

Represent the interests of ORs and NCM

Cooperate with regulators and other stakeholders in the process

Protect non-EU manufacturers from discrimination through REACH and EU against WTO/ TBT claims

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ORO - Facts & Figures

ORO has currently 36 Members (and further requests for joining)

ORO Members: are acting ORs (Service Providers) serve >2.400 non-EU Manufacturers handle >10.000 chemical substances cover >10.000 of importers

all over the EU/EEA pre-registered >15.000 substances registered >3.200 substances

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Distribution of Principalsby Region:1. Asia2. North America (NAFTA) 3. Europe – not in REACH4. Middle East5. South/Middle America6. Africa7. Oceania

Non-Community-Manufacturers from all over the world

ORO - Facts & Figures

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0,10%

0,20%

3,35%

8,17%

13,98%

74,21%

0,00% 10,00% 20,00% 30,00% 40,00% 50,00% 60,00% 70,00% 80,00%

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Registration until 2018

Registration until 2013

Registration until 2010

Intermediates in all thresholds (Transported Isolated, Phase-in)

Non-Phase-In Substances

Non-Phase-In Intermediates (Transported Isolated)

Substances of ORO Members by Type and Registration Deadline*

ORO - Facts & Figures

* According to ORO Surveys conducted from 2010 - 2014

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REACH Introduction REACH introduced globally new area of chemicals management and impacts

on a wide range of companies across many sectors, even those who may not think as being involved with chemicals.

REACH applies to legal entities in EEA only, companies outside but exporting into EEA customs territory not bound by REACH obligations.

Responsibility for fulfilling REACH requirements is with EU-importers, jurisdiction limited to EU territory. Authorities no competence to enforce outside.

Non-EU Manufacturer export into the EU via several importers, each importer shall make a separate (pre-)registration.

If Non-EU Manufacturer prefers to register on behalf of his EU-importer, REACH allows appointing an Only Representative (OR) located in EU (REACH Article 8).

OR takes over certain obligations on behalf of the exporter. This relieves (eventually) EU importers within same supply chain from some of their duties; hence they become downstream users.

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REACH Article 8

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Status of EU Importers Importer: any natural or legal person established within the Community who is

responsible for import. Import: the physical introduction into the customs territory of the Community.

Import shall be deemed to be placing on the market. Placing on the market: supplying or making available, whether in return for

payment or free of charge, to a third party. Responsibility for import depends on many factors such as who orders, who pays, who is dealing with the customs formalities, who owns the chemicals, but this might not be conclusive on its own.

In many instances it will be the ultimate receiver of the goods (the consignee) who is the legal entity that is responsible for the import. However this is not always the case.

EU Importers of substances or mixtures have considerable obligations under REACH (if not covered by an OR), comparable to those of EU Manufacturers.

Some complicated cases: import of mixtures with unknown composition import of products from indirect supply chains

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Responsibilities of Importers

Registration duties Importers regarded as Downstream Users, if registration covered by

supplier’s OR Substances in articles obligations (register, notify,…..)

Importers covered by a supplier’s OR for REACH are still “importers” under the scope of CLP CLP Notification CLP Labelling for supply Safety Data Sheet (SDS) for onward supply

Addressing SVHCs Respecting Restrictions Applying for Authorizations Communication and information duties

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Problem Case: SDS Responsibility SDS provision (REACH) and Labelling (CLP) are needed for supply of

hazardous substances, or mixtures containing hazardous substances above concentrations of concern, or if EU exposure limits have been designated.

Company who places substance on the market has the responsibility for SDS and C&L. This is not the OR!

If the OR is not commissioned by the non-EU supplier to prepare the SDS, OR only receives information on the supply of the SDS and is therefore not responsible for the content. If OR is a joint registrant he carries responsibility for ensuring information is available on hazard and exposure data (e.g. CSR).

Non-EU manufacturers have no official role in SDS provision or labelling, but need to take a responsible role in cases not directly covered by the legal text, such as supplying mixtures where different ORs are covering different components.

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Problem Case: Indirect EU-Imports In a multi-level non-EU supply chain, the non-EU manufacturer of a

substance usually does not know through which channels, in which products and finally how much volume of his substances is being imported into the EU.

Components of products, suppliers and customers is CBI of traders and formulators.

Antitrust rules need to be followed.

Neither the non-EU manufacturer (represented by the OR) nor the importercan fulfill the obligations without disclosing CBI and potentially leading to loss of business.

Solutions (tracking systems) exist without disclosing CBI !!!

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Complex Supply Chains & REACH Compliance Challenges

EU

Non-EU Manufacturer A(Internal OR1)

Non-EU Manufacturer B(External OR2)

Non-EU Manufacturer C(External OR3)

Confidential mixture

Substance

EU Manufacturer

non-EU Manufacturer & Formulator

(External OR2)non-EU

Formulator

Re-Import Substance

Importer 1 Importer 2 Importer 3

Confidential mixture

Confidential mixture

OR:- Importer, Substance &Volume tracking

- Supplier REACH coverage- SDS tracking- SME verification

Supplier: - SDS compilation andcommunication (including ES)

- Supplier REACH coverage

Importer:- C&L Notification- Supplier REACH coverage

Substance

OR1

OR2

OR3

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Recommendations for Importers Understanding roles & responsibilities in supply chain. Having a system in place (substance inventory, volume tracking…). Maintain a

database of all substances related information for at least 10 years from the date you imported the substance or mixture.

Integrate REACH responsibilities into sourcing agreements with non-EU suppliers. If own (pre-)registration is not an option, source only verifiable REACH (pre-)

registered chemicals from OR covered value chains. Request Cover Statements/Import Certificates of the OR through supplier. Ask for REACH compliant SDS and coverage of uses from supplier. OR can make the CLP-Group Notification for imported substances as OR, the

responsibility is on the importer to document this ! Late pre-registration deadline is 31.5.2017 in case you need to register yourself. Be aware that imports of SVHCs have specific requirements, even on products. Communicate exposure & hazard information to downstream users via SDS and

use Information upstream (e.g. for registrations and authorizations).

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Importer Coverage

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ORO – Best Practice Guide

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Further Reading

REACH – Best Practice Guide to Regulation (EC) No 1907/2006

Drohmann/Townsend,REACH-RegulationHardback, 2013 579 pp.ISBN 978-3-406-60320-4www.beck-shop.de/31044

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Only Representative Organisation (ORO) AISBL

Chaussée de Roodebeek 206B-1200 Brussels, Belgium

drohmann@onlyrepresentatives.org www.onlyrepresentatives.org

Thank you for your attention