Chemical Watch Expo 2017 April 25 and 26 , 2017 | Berlin · 2017-05-02 · Obligations | First Thing to do for REACH • REACH governs the manufacture, import and the placing on the

Chemical Watch Expo 2017April 25th and 26th, 2017 | Berlin

What is your REACH role?

Table of Contents

1. Your REACH Role Determines your REACH (& CLP) Obligations

2. Case of EU Manufacture and EU Import

3. Case of EU Downstream User (incl. Formulator)

4. Case of EU Chemical Trader, Packer, Agent

5. Case of non-EU Manufacturer and Formulator

6. Case of non-EU Chemical Trader, Packer, Agent

7. Conclusions / Key Messages

1. YOUR REACH ROLE DETERMINES YOUR REACH (& CLP) OBLIGATIONS

2. CASE OF EU MANUFACTURE AND EU IMPORT

3. CASE OF EU DOWNSTREAM USER (INCL. FORMULATOR)

4. CASE OF EU CHEMICAL TRADER, PACKER, AGENT

5. CASE OF NON-EU MANUFACTURER AND FORMULATOR

6. CASE OF NON-EU CHEMICAL TRADER, PACKER, AGENT

7. CONCLUSIONS / KEY MESSAGES

• Substances, on their own

or in mixtures

• Articles containing

Substances of Very High

Concern (SVHC) or intended

to be released

• Manufacturers (M),

Importers (I) and

Downstream Users (DU) of

substances on their own or in

mixtures

• Producers, importers and

suppliers of articles

• Exempted substances (e.g. waste, transport of

dangerous goods, radio-active

substance)

• Specific exemptions (e.g. no

registration, if below 1 t/a)

Non-EU companies

“Objects” “Subjects”

Within

scope

Out of

scope

Your REACH Role Determines your REACH (& CLP)

Obligations | The Objects and Subjects of REACH

The CLP Regulation essentially use the Same “Subjects” and “Objects”

(and definitions) as the REACH Regulations

Your REACH Role Determines your REACH

(& CLP) Obligations | How to Tackle REACH Successfully → Where to Begin

1. Determine your chemical portfolio in

terms of substances

– Substances on their own

– Mixtures: substances in mixtures

– (Articles: which substances are released

from them, not very common case)

2. Identify your REACH role per substance

3. Comply with REACH

Picture courtesy of ECHA

Focus of this

presentation


Obligations | First Thing to do for REACH

• REACH governs the manufacture, import and the

placing on the market and use of chemicals.

• Therefore, in order to be able to comply with REACH,

it is essential to determine ones (Company / legal

entity's) REACH role or roles per substance you are

“handling”.

– The first “obligation” of the REACH Regulation is the

self-determination of your role(s)

Manufacturer of substances

Importer of substances /

mixtures

Distributor substances /

mixtures

Downstream user of substances /

mixtures (incl. formulator of

mixtures)

Non-EU/EEA company

(Manufacturer / Formulator)


Obligations | Main REACH Roles

Ref. → REACH Art. 3.8 & 3.9, 3.10 & 3.13, 3.14, 3.13, 8

Lets look at each of there Roles in more detail and what the related

REACH / CLP obligations are








Case of EU Manufacture and EU Import

Definitions of these Roles

• Manufacturer: Company (“Legal entity”)

established within the Community who

manufactures a substance within the

Community

– Manufacturing: Production or extraction of

substances in the natural state

• Importer: Company established within the

Community who is responsible for import

– Import: The physical introduction into the

customs territory of the Community (EU / EEA)

→ Determining who actually is the

importer can be quite tricky and

may require a “legal analysis”…


Main Obligations of REACH for these roles

1. Companies manufacturing in or importing

into the EU/EEA substances over 1 tonne

annually, are required to REACH Register

the substance (unless specifically exempted)

– The purpose of the registration is to collect

information about the intrinsic properties of

the substance and their related risks to the

European CHemicals Agency’s (ECHA)

• Detailed information available on the ECHA

website (non-confidential information)

– Substances are to be either Lead

Registered or Co-Registered (when a Joint

submission already exists)


Main Obligations of CLP for these roles

1. Manufacturers and importers (“Suppliers”)

of a hazardous substance or mixture must

Classify, Label and Package these, regardless

of its annual tonnage, in accordance with the

CLP Regulation before placing it on the EU

market.

2. Manufacturers and importers (or groups of

them) need to Notify C&L of substances to

the ECHA C&L inventory (unless they have

REACH registered the substance).

• What is a Toll manufacturer:

– A toll manufacturer (common synonyms: Toller, Subcontractor,

contract manufacturer, Custom chemical manufacturer) is normally

understood to be a company that manufactures a substance in its

own technical facilities following the instructions of a Principal

(“Customer”) in exchange for an economic compensation.

– The substance is generally put on the market by the Principal.

• The REACH Regulation does not

have specific provisions for

toll manufacturing.


“Special case”: Toll Manufacturers


“Special case”: Toll Manufacturers

• General rules apply on Toll Manufacturers → Any EU Manufacturer

of a substance in a quantity of 1 tonne or more per year must

register the substance, unless specific exemptions apply.

– According to ECHA it is not relevant who owns the raw-material, the

know-how or the end product (= usually with the Principal)

• The Principal is only the Distributor and as such cannot register

(unless as an EU Importer)

• Special case: If the legal entity practically undertaking the

manufacturing process is different from the legal entity owning

the production facility, one of these entities must register the

substance (→ ECHA Registration Guidance).

Toll manufacturing is often misunderstood in industry because it is

the Principal who places the chemical on the market. The Toller is only working

for the Principal according to its instructions and does not know the final

customer(s) and their uses.

Case of EU Manufacture and EU ImportDeeper Look on Registration - Why it is important to be

active as part of the Joint Registration process (Page 1/2)

• As a Lead Registrant:

1. You cannot be anything else than active because

(amongst others):

• You have the responsibility to

1. Lead the Joint Submission work, and;

2. Prepare the Joint Submission Dossier on behalf of your Co-registrants.

• You will be the contact point for the authorities and ECHA with

regards to the Joint dossier (Joint Submission) and its content.

• You could be liable towards the Co-Registrants and your

customers so better get it right!

Case of EU Manufacture and EU ImportDeeper Look on Registration - Why it is important to be

active as part of the Joint Registration process (Page 2/2)

• As a Co-Registrant (for a substance to be registered by May 2018):

– You should take care who you select as the Lead Registrant

– You should take part in “leadership groups” (etc.) within the SIEF and

be an active SIEF member as then you know what the status is with the

development of the Joint Submission by the Lead Registrant.

– You should make sure the Substance Sameness criteria are correct and

good for you (once agreed the “formal SIEF” is established)

• Very important to get this right with all possible impurities and concentration

ranges from the start as this determines your substance “hazard profile” and

affects the CSR incl. Exposure Scenarios (where relevant)

– You should in any case communicate on a regular basis with the Lead

Registrant / “leadership group” to stay on top of the development of the

Joint Submission Dossier

– You could be liable towards your customers do better get it right!








Case of EU Downstream User (incl. Formulator)

Definitions of the Roles

• Downstream User (DU): Legal entity established within the

Community, other than the manufacturer or the importer, who

uses a substance, either on its own or in a mixture in the course

of his industrial or professional activities.

• Use: Any processing, formulation, consumption, storage, keeping,

treatment, filling into containers, transfer from one container to

another, mixing, production of an article or any other utilisation

• Formulator: Formulators are downstream users who produce

mixtures and usually supply them further down the supply chain or

directly to consumers. They mix together substances and/or

mixtures, with no chemical reaction taking place during the

process. (ECHA website)


Main Obligations of REACH for this role

1. Using chemicals safely according to the provide guidance of Safe

Use (SDS / eSDS or equivalent instructions)

2. Prepare Mixture (e)SDSs for hazardous mixtures the DU is placing

on the market

3. Making uses Known to the Supplier (REACH Article 37.2 & 37.3)

4. If the DU’s use (≥ 1 t/a) is not included in the registrant’s

Exposure Scenarios communicated in the eSDS the DU needs to prepare a DU CSR within 12 months → Needs to be Report to ECHA

within 6 months of reception of the eSDS

5. Inform the supplier of any new information on the hazardous

properties of the substance supplied

6. Not use substances requiring an Authorisation (Annex XIV substances) without authorisation → The DU must inform ECHA of

the use of an authorised substance

7. Not use restricted substances


Main Obligations of CLP for this role

1. Downstream users (“Suppliers”) of a

hazardous substance or mixture must

also Classify, Label and Package these,

regardless of its annual tonnage, in

accordance with the CLP Regulation

before placing it on the EU market.








Case of EU Chemical Trader, Packer, Agent

Definitions of the Roles (Page 1/3)

• EU Chemical Trader: A company engaging in buying and selling of

chemicals without themselves manufacturing substances or

formulating mixtures.

– When this is the case, the EU Chemical Trader is regarded as a

“Distributor” according to REACH at most (→ Next page)

In some cases the EU Chemical Trader does take care of the import

of substances into the EU and is therefore regarded as an importer→ Check “Case of EU Manufacture and EU Import”

In some cases the EU Chemical Trader can also be the Only

Representative → Check “Case of Non-EU Manufacturer and Formulator”

• Packer: Is packaging (incl. re-packaging) chemicals. Considered as

downstream users in the context of REACH and CLP → Check “Case of

EU Downstream User (incl. Formulator)”



• Agent: A Company typically engaging in

facilitating chemicals trade between other parties

for a fee not having any REACH role itself

→ Therefore, no REACH or CLP obligations

and will not be discussed further in this

presentation



Therefore, hence forth only focusing on “Distributor” role as

relevant for REACH and CLP

• Distributor: A legal entity established within the Community,

including a retailer, who only stores and places on the

market a substance, on its own or in a mixture, for third

parties.

→ (Only) storing and placing on the market, not using.


Main Obligations of REACH for this role (= Distributor)

1. Pass (e)SDS and other Guidance on Safe Use forward to

customers

– Information flow down the supply chain ↘

– The distributor may also issue their own (e)SDS / Guidance on

Safe Use

2. Inform the supplier of any new information on the

hazardous properties of the substance supplied (whether

based on own information or information coming from the

customers)

– Information flow up the supply chain ↗


Main Obligations of CLP for this role (= Distributor)

• There are no direct CLP related requirements for the

distributor

– If however the distributor re-labels any of the packages, this

has to be done according to the CLP Regulation.








Case of Non-EU Manufacturer and Formulator


• Non-EU Manufacturer and Formulator: Any company

outside the EU/EEA that manufactures substances and/or

formulates mixtures

• Standard definitions of the “Manufacturer” and

“Formulator” apply…


Main Obligations of REACH for this role

• Non-EU Manufacturers and Formulators do not have any REACH

obligations, however…

• Under REACH Article 8, Non-EU Manufacturers and Formulators have

the right to appoint an Only Representative (OR) to take care of

the REACH obligations of the EU importers (e.g. REACH registration)

– The Only Representative has to reside in the EU / EEA (→ BREXIT implications… No more OR’s in the future in the UK)

– Importer obligations have been discussed earlier → Check “Case of EU

Manufacture and EU Import”

• Having an OR will relieve the EU importers within the same supply

chain from their registration obligations, as they will be regarded

as downstream users.

– → Check “Case of EU Downstream User (incl. Formulator)”

Note: Only Non-EU Manufacturers and Importers

can appoint an Only Representative!


Main Obligations of CLP for this role

• Non-EU Manufacturers and Formulators do not have any CLP

obligations.

• Special note: In REACH the EU importers covered by an Only

Representative are regarded as downstream users but this

exemption does not apply to CLP requirements for the EU

importers

– Only Representatives are not foreseen under CLP and cannot

CLP notify (ECHA), only the EU importers can

– However, the Only Representative may organise a Group CLP

notification covering the EU importers of the Non-EU

Manufacturer / Formulator.


“Special case”: Non-EU Toll Manufacturers

• Any Non-EU Toll Manufacturer (who manufactures a substance

or formulates mixtures with substances that are placed on the EU

market at ≥1 t/a) may appoint an EU Only Representative

Note: The principal cannot appoint the OR as it does

not manufacture the substance or formulate the

mixture.

• → Optionally the EU importers can take care of REACH

obligations individually.








Case of Non-EU Chemical Trader, Packer, Agent


• Non-EU Chemical Trader, Packer, Agents are typically

not engaging in either manufacture or formulation of

chemicals and therefore do not have any REACH roles.

Case of Non-EU Chemical Trader, Packer, Agent

Main Obligations of REACH and CLP for this role

• No legal role and therefore cannot appoint an Only-Representative → Nothing to do!

Non-EU chemical traders cannotappoint an Only Representative…








What is your REACH role?

Conclusions / Key Messages

• In order to be able to comply with REACH (&CLP), you will need to

know your REACH ROLE per substance that you are handling (manufacturing, importing, distributing, downstream using, as such or as

part of a mixture or even an Article in special cases).

– If you get your roles wrong, you are most likely non-compliant with

REACH (and CLP) → Get it Right!

• A EU Toll manufacturer is almost always the REACH ”Manufacturer ”

and has to comply itself with the related REACH and CLP

obligations.

• As a Non-EU Manufacturer and Formulator, you can appoint an OR

to take care of REACH importer obligations whereas your customers

in the EU importing the substances will be considered as Downstream Users → Efficient!

– Non-EU toll manufacturers have to appoint the OR, not the Principal

Additional off-topic note:Late-pre-registrations will NOT be

possible after 31st of May 2017

Thank you for your attention

Frederik Johanson

Partner-Sales

REACHLaw Ltd.

[email protected]

+358 40 059 5918

Contact details

R E A C H L a w L t d . | V ä n r i k i n k u j a 3 J K 2 1 | F I - 0 2 7 6 0 E s p o o | F I N L A N D

Additional SlidesMain REACH and CLP

Obligations Listed per Role

Manufacturer and EU Importer REACH Obligations

General obligation to register substances on their own or as part of mixtures (Art. (5), 6, 21)

Registration and notification of substances in articles (Art. 7)

Duty on the sharing of data involving tests with same SIEF members (Art. 30)

Duty to jointly submit data with multiple registrants (Art. 11)

Information to be submitted for general registration purposes and depending on tonnage (Art. 10, 12, 13)

Duty to produce a Chemical safety report and duty to apply and recommend risk reduction measures(Art. 14)

Duty to classify and label substances (Art. 112, 113)

Duty to take into consideration a downstream users use of a substance with the aim of making this an identified use in the substance registration (Art. 37.1, 37.2)

Duty to update information that has been provided to the agency as a consequence of the registration completeness check (Art. 20.2)

Duty to update ones own registration (Art. 22)

Registration deadline for substances not fulfilling the phase-in status, will be regarded as new substances and cannot rely on deadlines provided for phase-in substances (Art. 140.2, 26, 23)

Duty to register on-site isolated and transported isolated intermediates and joint submission of data by multiple registrants (Art. 17, 18, 19)

The registrant will respond to any request to provide further data or to update the registration documents (for both regular substances and on-site isolated intermediates) as part of the evaluation process (Art. 40.1, 41, 42, 43, 46, 49)

Duty to be in compliance with any restrictions placed on substances as such, in preparation or in articles (Art. 56.1)

Duty to apply for an authorisation (ECHA) for substances included in REACH Annex XIV (substances of high concern), as substances as such, in preparations or articles, before a sunset date, and making subsequent applications for authorisation (Art. 56.4, 58.1a, 62, 63 )

Obligation of the holders of authorizations to include the authorization number on the label before they place the substance or a preparation containing the substance on the market for an authorized use (Art. 65)

Prepare SDS for dangerous substances of preparations placed on the market where necessary and pass the SDS to customers (Art. 31, Annex II)

Duty to provide a SDS at the request of a downstream user (recipient) (Art. 31.3 , Annex II)

Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety data sheet is not required (Art. 32)

Any supplier of an article containing a substance meeting the substance in article criteria in a concentration above 0,1 % (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance (Art. 33 (57, 59.1))

Workers exposed to substances/preparations in the course of their work shall be granted access to information regarding the substance (SDS or equivalent) (Art. 35)

The M/I shall assemble and keep available all information that is requires to carry out his duties under REACH for a period of at least 10 years after he last manufactured/Imported the substance or preparation (Art. 36)

Duty to comply with any restrictions set on the manufacture or placing on the market of a substance on its own, in a preparation or in an article (Art. 67, Annex XVII)

… Continued

Manufacturer and EU Importer CLP Obligations

Manufacturers, importers and downstream users have the obligation to classify substances and mixtures placed on the market (Art. 4, 13, 14)

Suppliers have the obligation to label and package substances and mixtures placed on the market (Art. 17, 35)

Manufacturers and importers of substances have the obligation to notify the Agency of such classifications and label elements if these have not been submitted to the Agency as part of a registration under Regulation (EC) No 1907/2006 (Art. 40)

Manufacturers, importers and downstream users shall take all reasonable steps available to them to make themselves aware of new scientific or technical information that may affect the classification of the substances or mixtures they place on the market. (Art. 15)

The supplier shall assemble and keep available all the information used by that supplier for the purposes of classification and labelling under this Regulation for a period of at least 10 years after the substance or the mixture was last supplied by that supplier. The supplier shall keep this information together with the information required in Article 36 of Regulation (EC) No 1907/2006 (Art. 49)

Downstream User REACH ObligationsDU’s have the right to make a use known to their supplier with the aim of making this an identified use. They must provide sufficient information (as a minimum the brief general description of use) for the supplier to develop an ES. DU’s may also provide information to assist in the preparation of the registration (Art. 36.7-37.2)

DUs shall identify and apply appropriate measures to adequately control risks associated with the use of a substance/preparation (e.g. SDS or any other risk management measures (RMM) available) (Art. 37.5)

Where the DU’s own use is not covered and can't be incorporated within ES of the substance registration, a DU CSA (DU-CSR) have to be carried out, if used in quantities over 1 t/a. Report use to ECHA (Art. 37.4)

Use authorized substances only within the conditions in the authorizations and notify the ECHA about the use (Art. 56.2, 66)

Comply with any restrictions on the use of substances and preparations (Art. 67.1)

Inform the supplier of any new information on the hazardous properties of the substance supplied (Art. 34)

Communicate to the supplier any information that might call into question the appropriateness of the RMMs included in the ES’ (Art. 34)

Prepare SDS for dangerous substances of preparations placed on the market where necessary. Pass SDS to customers (Art. 31)

For substances and preparations where a SDS is not required, provide basic information to customers on substances within the preparation, whether subject to authorization and restriction, and RMM information (Art. 32)

Any supplier of an article containing a substance meeting the substance in article criteria in a concentration above 0,1 % (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance (Art. 33 (57, 59.1))

The DU shall as part of the evaluation process submit the information to the ECHA by the deadline set, if required. (Art. 40.4)

Workers using substances in the course of their work or may be exposed to, shall be granted access to information regarding the substance (SDS or equivalent) . (Art. 35)

The DU shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last used the substance or preparation (Art. 36)

Downstream User CLP Obligations / Duties

Manufacturers, importers and downstream users have the obligation to classify substances and mixtures placed on the market (Art. 4, 13, 14)


Manufacturers, importers and downstream users shall take all reasonable steps available to them to make themselves aware of new scientific or technical information that may affect the classification of the substances or mixtures they place on the market. (Art. 15)


Distributor REACH Obligations

Inform the supplier (e.g. manufacturer) of any new information on the hazardous properties of the substance supplied (Art. 34)

Pass SDS forward to customers (Art. 31)

For substances and preparations where a SDS is not required, pass forward basic information to customers on substances within the preparation, whether subject to authorization and restriction, and RMM information (Art. 32)

Any supplier of an article containing a substance meeting the substance in article criteria in a concentration above 0,1 % (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use ofthe article including, as a minimum, the name of that substance (Art. 33 (57, 59.1))

Workers being exposed to substances in the course of their work shall be granted access to information regarding the substance (SDS or equivalent) . (Art. 35)

The Distributor shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last used the substance or preparation (Art. 35)

Distributor CLP Obligations



Non-EU Manufacturer and/or Formulator REACH /CLP “Obligations”

There are no REACH or CLP obligations for the Non-EU Manufacturer and/or Formulator but:

Any Non-EU company that manufactures a substance or formulates mixtures with substances that are placed on the EU market at ≥1 t/a may appoint an EU Only Representative (REACH Art. 8)

Documents

Chemical Watch Expo 2017 April 25 and 26 , 2017 | Berlin · 2017-05-02 · Obligations | First Thing to do for REACH • REACH governs the manufacture, import and the placing on the