how downstream users reach? impacts and challenges of reach

The European Engineering Industries Association

How Downstream Users REACH?

Impacts and challenges of REACH

for EU Cutlery, Flatware, Holloware, and Cookware Industries

FEC General Assembly

20 November 2007

Françoise Duplat

Orgalime secretariat


ES

UKIE

BE

LU

NL

CH

FR

PT IT

DE

DK

NO

PL

SL

CZ

SE

FI

LV

LT

BG

• 35 Member Associations

• 23 European Countries

• 130 000 Companies

• €1779 Bn output 2006 (EU-27 estimates for the whole engineering industry)

• 10.6 Mio employment

AT

HR


Brief outline

Introduction REACH priorities for DU

Communication in the supply chain Substances in articles Authorisation procedures

Conclusion


Why « REACH »? REACH: « Registration Evaluation Authorisation of Chemicals » Before REACH – various legislation relating to chemicals :

Directive 67/548/EEC, Directive 1999/45/EC, Regulation (ECC) n° 793/93, Directive 76/769/EEC etc

BUT lack of harmonisation between so-called «new» and « existing» substances

Therefore elaboration of « REACH Regulation » Publication of the COM Proposal on REACH: 29 Oct. 2003 Negociation European Parliament and Council: end of 2003-Dec. 2006 European Regulation n° 1907/2006 adopted 18 Dec. 2006 Publication in EU Official Journal : 30 Dec. 2006

Creation of European Chemicals Agency (ECHA)


REACH Regulation n°1907/2006

Entered into force on 1st June 2007

Directly applicable and full harmonisation except enforcement

Strengthened industry responsibility to provide and communicate safety information on substances and to properly manage the risk realted to their use.

Scope: All substances, on their own, in preparations, in articles Exemption to scope: radioactive, non-isolated intermediates, waste, transport, transit or

reexportation, interest of defence

Further exemptions to some parts of REACH, e.g. for R&D, acc. to use, nature of substance etc

All EU actors of supply chain concerned: from e.g. EU manufacturer/importer (M/I) of substances to downstream users (DU)/article producer or article importer

REACH obligations according to role in supply chain


Orgalime practical guide for downstream users, article producers and article importers to understanding Regulation N°1907/2006 on REACH (May 2007)

Available free of charge at www.publications.orgalime.org

Structure:

Introduction (definitions, acronyms etc.)

Overview important dates and deadlines

Orgalime quick screens

More detailed guidelines on selected issues

One page summary on timelines and obligations

Substance manufacturer/

importere.g. chemical industry

Formulator of preparations

(“1st level downstream users”)e.g. paint manufacturer

Downstream users of substances/preparations

(“2d level downstream users”)

Orgalime Industries FEC industries

Article producers/Article importers

Orgalime IndustriesFEC industries

What focus for Orgalime?


REACH prioritiesfor Orgalime industries

In the context of registration of substance:

Communication in the supply chainTitle V (mainly)

Registration of substances intentionally released from articles under certain conditions

Article 7

Notification of substances of very high concern present in articles under certain conditions

Article 7

Communication requirements on substances of very high concern present in articles under certain conditions

Article 33

Use of authorised substances/application for authorisation for substances included in Annex XIV REACH

Title VII

??Check Orgalime quick screens 1,2,3,4


Establish inventories

with key information

according to role

What is my role in the supply chain?

First and foremost…

Downstream user? Importer?

(« only representative»

nominated in the EU?) Article

producer/importer?

A company may play

several roles!

Takes time and

ressources -

early preparation

is key

Check REACHscope/exemptions

??Check Orgalime Guidelines 1,2,3,4

Downstream user means….“any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities (…)

Article producer means….“means any natural or legal person who makes or assembles an article within the Community”


Registration procedurein a nutshell

Registration of substances on their own or in preparations, intentionally released from articles ≥ 1 t/y per M/I

For “non phase-in substances” ≥ 1 t/y: as of 1/06/2008, before

manufacturing/importing/putting on the market For “phase-in” substances ≥ 1 t/y: transitional regime

≥1000 t/y, CMR ≥1 t/y, aqu.tox. ≥100 t/y : 30 /11/2010

100 - 1000 t/y: 31/05/2013

1- 100 t/y : 31/05/2018

To benefit from transitional regime: PRE-REGISTRATION required!

“No data - no market”

DU to communicate uses to allow manufacturer/importer (i.e. supplier) to complete registration dossier

·


Communication in the supply chain (1)

ESSENTIAL to ensure that substances used will be pre-registered/registered by supplier

Pre-registration : between 1/06/2008 and 1/12/2008 (Art. 28) DU not considered as potential registrant List of pre-registered substances on the ECHA website by 1/1/2009 Notification to Agency of interest for a non pre-registered substances DU may be part to Substance Information Exchange Forum (SIEF)

??Check Orgalime guideline 5

« No data - No market »Possible consequences on continuity of supply

Time is running!



Supplier (M/I) to compile registration dossier Technical dossier: starting at 1 t/y

Chemical safety report (CSR): starting at 10 t/y

CSR to include exposure scenario (ES) if substance is dangerous, PBT or vPvB

ES to cover manufacture of sub. and DU identified uses

DU «identified use» covered ? DU has the right to make his use known to supplier (« brief description of use »)

DU to provide sufficient information to allow supplier to prepare exposure scenario/use and exposure category (ES/UEC) for his use

ES annexed to safety data sheet (SDS)



Important to BE PRO-ACTIVE and inquire early enough on supplier’s policy towards substance/preparation used


Possible uses advised against, but only for reasons of protection of human health or the environment

If no SDS but risks management measures (RMMs): Article 32

DU to identify, apply and where suitable recommend RMMs ( listed in SDS or Article 32)

12 Months to comply with Art. 37 after receiving registration number in SDS

Further DU communication duties



DU own chemical safety report

Specific cases : DU to perform own chemical safety report (CSR) and report to ECHA (Art. 37.4, 38 and Annex XII) for:

Use outside conditions described ES/UEC of supplier Use advised against (protection of health and the environment)

DU to identify, apply and where suitable recommend RMMs of his own CSR

Information to be kept available and up to date Exemptions foreseen!


Requires specific chemical knowledge Time consuming and expensive

Make sure supplier’s ES covers DU uses


Substances in articles

What is an « article »?

“an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition” (Art. 3.3)

?? Check Orgalime Guidelines 7,8,9

E.g.: electrical and electronic equipment, a screw, a bolt, a motor, cutlery, cookware, etc.


Registration of substancesintentionally released from articles

Article producer,article importer/«only representative» to REGISTER any substance in articles if

Intentional release under normal or reasonably foreseeable conditions of use AND

Total amount of substance present in articles over 1 tonne per producer/ importer per year (Art. 7.1)

Same timeline to register as for any other substances (2010-2013-2018) - Registration fees

NO registration of substance in article if substance has already been registered for that use (Art. 7.6)

Check Orgalime guideline 7??


Notification of substances present in articles ??

Check Orgalime guideline 8

Article producer,article importer/«only representative» to NOTIFY substances in articles if the substance

Has been identified as of very high concern (Art.57) i.e. CMR 1 & 2, PBT/ vPvB and any other substance of equivalent concern AND

Is present in articles in quantities over 1 t/y AND Has been included in the candidate list (Art.59) AND Is present in the article above a concentration of 0.1% w/w (Art. 7.2)

FROM 1/06/2011, 6 months after inclusion in candidate list

Notification of substance in article NOT required If substance has already been registered for that use (Art. 7.6) If exposure to human health and the environment, including disposal, can be

excluded (appropriate instructions to recipient) (Art. 7.3)


Further points to consider….

ECHA to possibly require registration for substances present in articles under certain conditions (Art. 7.5)

Concentration calculation « 0.1% w/w » at the level of the article

Consequences on smooth running of supply chain and just in time delivery of articles


Communication requirements on substances in articles

Supplier of an article to provide sufficient information available to him, as a minimum name of substance, to recipient of article to allow safe use if the substance

Is identified as of very high concern AND Is included in the candidate list for inclusion in Annex XIV AND Is present in the article in concentration above 0.1% w/w

Extended to consumers upon request (within 45 days free of charge)

?? Check Orgalime guideline 9


Authorisation procedure (1)

Concerns substances of very high concern on their own/in preparations/ incorporated in articles during process phase

« Progressive» procedure: Sub. incorporated in the candidate list Priority list from ECHA no later than 01/06/09 Further inclusion of sub. in Annex XIV Application for authorisation (by M/I/DU - analysis of alternatives - fees!) COM to decide on granting/reviewing authorisation

NO tonnage threshold DU may use a substance listed in Annex XIV if authorisation granted

for that use up the supply chain Notification to ECHA within 3 months of first supply! Exemption certain uses and categories of uses Further exemptions foreseen!

Two routes foreseen



Authorisation procedure (2)

An authorisation for the use of a substance listed in Annex

XIV will be granted only if :

Risks adequately controlled, OR

Adequate control cannot be demonstrated but it is shown

that socio-economic benefits outweigh the risk to

human health or the environment arising from the use of

the substance and if there are no suitable alternative

substances or technologies.



Possible consequences of authorisation procedures

Substance withdrawal from the market Disruption in the supply chain Technology changes Costly and time consuming procedures

(analysis of alternatives and where such alternative exists – substitution plan)

DU to make sure that the substance used is authorised for his use up the supply chain


Is there an alternativesupplier who will cover

your use?

4.1. Orgalime REACH Quick Screen 1 Registration of substances/substances in preparations

used in industrial (including engineering) processes

Make substance inventory:Do you use substances/preparations

in your industrial processes?See guideline 3

Are the substances/substances in preparations

exempted from registration?See guideline 2

Do you import substances/preparations

from outside the EU?See guideline 4

No further requirement

Will the supplier pre-register/register the substance/substances

in preparations? (Art. 28)

yes

Does your non EU supplier have an only

representative in the EU? (Art.8)

yes

•You act as importer of substance/preparation and mayhave to pre-register/registerthe substance on its own/in preparation (Art. 6)•If Svhc: check OrgalimeQuick Screen 2

no

no

yes

yes

Is there an alternative supplier in the EU

who will pre-register/register?

no

•Identify, apply and where suitable recommend risk management measures communicated to you

in safety data sheet or in information communicated to you in accordance with Article 32.See guideline 5•If substance of very high concern (Svhc): check Orgalime Quick Screen 2

•Carry out your own chemical safety report (Art. 37.4, Annex XII)Check exemptions!•Report to the Agency (Art. 38). •Identify, apply and where suitablerecommend risk management

measures (Art. 37.5).See guideline 6•If Svhc: check OrgalimeQuick Screen 2

Will the supplier cover your usein his registration file? (Art. 37)

yes

no

yes

•Only representativewill act as importerand has to register the substance (Art. 6) •You are a downstream user:check whether your use will be covered.See guideline 5

Supply of substance in the EU will no longer be possible (« no data - no market »):You may re-consider alternative supplier outside the EU/notify the Agency of your interest for that substance (Art. 28.4 and 28.5).See guideline 5

no

yes

Is there analternative supplier

in the EU?

no

yes

no


no

no

RECOMMENDATIONS:•Start your substance inventory NOW. •Start communicating with suppliers EARLY: to ensure continuous supply of a substance, be PRO-ACTIVE, don’t wait until the supplier has registered the substance you are using in processes to start communicating! •Make sure the substance you use will be pre-registered. In case the substance you use has not been pre-registered, you have the possibility to notify the Agency of your interest in that substance. The Agency shall publish on its website the name of that substance and, on request, provide your contact details to a potential registrant (Article 28.5 REACH). Transition periods for registration will however not be allowed.

•Check also Orgalime Quick Screens 2, 3 and 4 for further possible obligations.

yes

13

•Only representativewill act as importerand has to apply for Authorisation.•You are DU: make sure your use will be included in the application for authorisation.See guideline 10

Make substance inventory: do you use substanceson their own/in preparations identified as substances of

very high concern (Svhc)? (Art. 57)

Do you import Svhc/preparations containing Svhc

from outside the EU?See guideline 4

no

yes

4.2. Orgalime REACH Quick Screen 2REACH authorisation procedures

No furtherrequirement

Does your non EU supplier have an only

representative in the EU? (Art.8)

•You act as importer of substance/preparation. •You may have to apply for an authorisation and cannot benefit from an authorisation granted to an actor up the supply chainfor that use.

See guideline 10

no

yes

Is there analternative supplier

in the EU?

Is the substance included in the candidate list (liable for authorisation)? (Art. 57 and 59)

Monitor Agency websiteand priority list (Art. 58.3)for possible inclusion of

substance in candidate list.

Is the substance listed in annex XIV?

yes

no

Do you wish to keep your use confidential?

Follow closely comitologyprocedure prior to inclusion of substance in Annex XIV.

yes

Is the substance or your use generallyexempted from authorisation?

(Art. 2, Art. 56.3 to 56.6)

Is your use /category of uses specifically exempted from

authorisation? (Art. 58.2)

Do you use a substance in accordance with the conditions of authorisation

granted to an actor up your supply chain? (Art. 56.2)

yes

yes

no

no

Notify the Agency within 3 months of first supply

(Art. 66.1). See guideline 10

yes

yes

Will your supplier apply for authorisation for your use?

no

no

Is there alternative supplierwho will apply

for authorisation for your use?

no

no

no

yes

no

yes

Apply for an authorisationfor your own use.

See guideline 10

yes

no

yes

RECOMMENDATIONS:

•Please be aware that authorisation may cause substance withdrawal from the market.

•Application for authorisation must include an analysis of alternatives (Article 62.4 REACH). Please consider

Article 62.4 REACH at an early stage, especially if the use of the substance is critical to your processes.


Notify the Agency within 3 months of first supply (Art. 66.1).

See guideline 10



Has the sunset date been reached? You may no longer use the substance unless the request for an authorisation has been made at least 18 months before the sunset date and the decision is still pending (Art. 56.1).

yes

no

14

4.3. Orgalime REACH Quick Screen 3Registration of substances intentionally released from articles

Make inventory of substances intentionally released from the article:Are they exempted from registration?

See guidelines 2 and 3

Has the substance in the article been already registered for that use? (Art. 7.6)

no

no

yes

Make inventory of articles:Do you produce in the EU articles that

intentionally release substances or do youimport such articles from outside the EU?

yes

Is the substance present in article in quantity over 1 tonne per

producer/importer per year? (Art. 7.1)

Is the substance intendedto be released under normal and

foreseeable conditions of use? (Art. 7.1)

yes

•You have to register the substance (Art. 7.1). •If phase-in substance, make sure the substance is pre-registered before 1 Dec. 2008 then register according to transition periods (Art. 23).•If non phase-in substance or not pre-registeredsubstance, register before manufacturing/importing/putting on the market.See guideline 7•If Svhc, check Orgalime Quick Screen 2

noIs the substance of very high

concern (Svhc)? (Art. 57)

Notification obligations under certain conditions and

duty to communicate information down the supply chain may occur.

No further requirements

yes

RECOMMENDATIONS:

Article producers/importers should pay attention under which provision of the REACH Regulation the intentionally released substance/substance in preparation should be registered:

•If the substance that requires registration is considered as a substance delivered in a container, the substance has to be registered according to Article 6 REACH. Please note that the container itself may be considered as an article according to Article 3.3 REACH.

•If the substance to be registered is considered as a substance in an article, the substance requires registration according to Article 7.1 REACH.


yes

yes

noNo further

requirements



no


no

Check Orgalime Quick Screen 4

15

Guide available free of charge at www.publications.orgalime.org

To know more….Orgalime REACH guide ??

Make inventory of articles:Do you produce articles containing substance of

very high concern (Svhc) in the EU orimport them from outside the EU?

Identify Svhc in articles:Has the substance in article

been already registered for that use? (Art. 7.6)

yes Does the article contain Svhc present in the candidate list above

concentration of 0.1% w/w?

(Art. 33)


•No notification needed•Communicate to article recipient/to customer upon request to allow safe use (Art. 33).See guideline 9•If Svhc added to Annex XIV, authorisation might apply. Check Orgalime Quick Screen 2

Is the substance present in article in quantity over 1 tonne per producer/importer per year?

Is the substance intendedto be released under normal and

forseeable conditions of use? (Art. 7.1)

yes

yes

no

no

no

yesYou have to register the substance (Art. 7.1).Check Orgalime Quick Screen 3If Svhc added to Annex XIV, authorisation procedures might apply. Check Orgalime Quick Screen 2

Is the substance in the candidate list? (Art. 59)

noObligations may occur,if Svhc is added to

candidate list: thereforemonitor Agency website

and priority list (Art. 58.3).Until then, present law

on restriction of useof Svhc applies.

yes

Is the substance above a concentration of 0.1%

weight by weight?

yes

Is there a risk of exposure to human and the environment during normal and foreseeable conditions of use

including disposal? (Art. 7.3)

yes

•You must notify substance present in article (Art. 7.2)as of 1 June 2011, 6 months after the substance has been included in candidate list (Art. 7.7).See guideline 8•Communicate to article recipient to allow safe use (Art. 33).See guideline 9•If Svhc added to Annex XIV, authorisation might apply. Check Orgalime Quick Screen 2

no•Supply instructions to recipient(Art. 7.3).•Communicate to article recipient/customer upon request to allow safe use (Art. 33).See guideline 9

no

yes

RECOMMENDATIONS

•According to Article 7.2 REACH, the calculation of the 0.1% w/w concentration refers to the article, not at the level of the homogeneous material.

•Please be aware that according to Article 7.5 REACH, the Agency may require you to register the Svhc under certain conditions.


4.4. Orgalime REACH Quick Screen 4 Notification of substances in articles and obligation to communicate information


no

From Quick screen 3

16


no


Conclusion

REACH : complex legislation New duties for inter alia downstream users,

article producers and article importers Important to prepare NOW Orgalime practical guide to understanding

REACH Regulation 1907/2006http://publications.orgalime.org/


Thank you for your attention!Orgalime

Diamant building 5th floor

80 Boulevard Reyers

1030 Brussels

[email protected]

Tel.:0032.(0)2.706.82.35

Fax.:0032.(0)2.706.82.50

www.orgalime.org

how downstream users reach? impacts and challenges of reach

Documents

substance inventory

supply of substance

eu supplier

registerregisterthe

alternative supplier

guideline 4noyes4

supplier preregisterregister

orgalime reach quick