REACH Regulation Basic requirements

REACH Regulation Basic requirements 1

REACH Regulation Basic requirements

Semira Hajrlahović Mehić, LL.M., B. Sc.Tatjana Humar-Jurič, M.Sc.


Content Background/Objectives/Scope REACH Core elements ECHA Conclusions Good to know


Background

Negotiations Before and after proposal

of October 2003 13.12. 2005: political

agreement End 2006: European

Parliament and Council agreement

Regulation 1907/2006

Content of REACH A whole lot… Very complex… REACH replaces > 60

directives and regulations


REACH Regulation

REGULATION (EC) No. 1907/2006 of the European Parliamenet and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

REACH Registration Evaluation Authorisation of CHemicals


Some starting pointsDifferent chemical policies for: Existing Substances

100,106 substances; 99% of market volume; Risk assessments for ± 140; Focus on > 1,000 tpa

New Substances ca. 3,000 substances;

Notification from > 10 kg pa

Furthermore Many existing substances not risk

assessed

Call for reducing animal tests Differences not good for internal market

not good for man and the environment


REACH in a bookshelf

I II III IV V VI

VII

VIII

II III IV V VI

VII

VIIIAnnexes:

Titles:

IX XI

XII

XIII

XIV XV

XV

I

IX X XI

XII

XIII

I

XIV XV

X

XV

II

Technical guidance……….


Who are the players? Manufacturer (M) Importer (I) Downstream user (DU) Agency European Commission Member States

Policy level Execution level

Inspection / Enforcement Third parties

ECHA (Helsinki) Central role Facilitating Executive Partly paid through fees


REACH “logic”

One single and coherent system for: New and existing substances Hazardous and non hazardous substances

Shift of responsibilities: public authorities industry

No data, no market


REACH Objectives

Protection of the human health and the environment

Promotion of alternative methods Free circulation on the internal market Enhancing competitiveness and innovation


REACH Core elements

Registration of substances ≥ 1 tonne/yr (staggered deadlines)

Information in the supply chain Evaluation of some substances by Member

States/ECHA Authorisation only for substances of very high

concern Restrictions - the safety net Agency (ECHA) to manage system


REACH.Registration, Evaluation, Authorisation and restriction

of CHemicals

RestrictionsAuthorisationEvaluationRegistration

CMR & PBT & equivalent concern

Substances of concern

> 10 tonnes/yr

+ substances of concern

> 1 tonne/yr


REACH Focus

Prioritieshigh volumes (as a proxy for potential risk)greatest concern (substances & uses

with highest risk)


No data, no market

Article 5“ Subject to Articles 6, 7, 21 and 23,

substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required”


Title II: Registration

Manufacturers/Importers Registration for substances ≥ 1 tonne per

year Chemical Safety Report (CSR) for all

substances ≥ 10 t per year


Scope of the Regulation

REACH applies to the manufacturing, import, placing on the market and use of substances On their own, in preparations, in articles

Exemptions for certain: Substances Uses of substances

Reduced obligations R&D, polymers and intermediates


Registration Aim

Manufacturers and importers obtain information on their substances

Use this knowledge to ensure responsible and well-informed management of the risks these substances may present throughout their life cycle


What is Registration

Submission of Dossier (Documentation) In case of absence of available

information, tests may be conducted Data sharing (in particular for vertebrate

tests) Substance Information Exchange Fora

(SIEFs)


What is Registration

Registration Dossier = Documentation Technical Dossier:

starting at 1 tonnes per year IUCLID 5

Chemical Safety Report: starting at 10 tonnes per year

REACH Regulation Basic requirements 1904/21/23 19

Who has to register?

Manufacturers of substances and producers of articles with intended release:

Each legal entity must register separately May appoint Third Party Representative

Importers Non-EU manufacturer may appoint Only Representative

instead In such cases, Only Representatives is liable for

registration and importer is considered as downstream user


Registration Exceptions

PPORD (notification still needed) for 5 years plus 5 or 10 (medicines) years

Pesticides (and co-formulants) Active ingredients of biocidal products Reduced registration for some (on-site and transported)

intermediates Joint submission of data (OSOR)

Mandatory sharing of data


Reach time table

phase-in substances → pre-registration (finished 1.12.2008)

CMR cat. 1,2 > 1 t/y (1.12. 2010) R50-53 subst. > 100 t/y (1.12. 2010) EINECS subst. > 1000 t/y (1.12. 2010) EINECS subst. > 100 t/y (1.06. 2013) EINECS subst. > 1 t/y (1.06. 2018) Obligation to register →since 1. 06 2008. Prolongation only for pre-registered substances

.


Reach time table

Non phase-in substances

1.06.2007 1.06.

2008

1.12.2008

30.11.2010

31.05.2013

31.05.2018

100-1000 tonnes

1-100 tonnes

RE

AC

H e

ntry

into

forc

e

> 1000 tonnesCMRs ( > 1 tonne)Very toxsic to aquatic organisms (R50/53) (> 100 tonnes)

Pre

-reg

istra

tion


Substances in Articles (Article 7)

Substance intended to be released (regardless of hazard)

> 1 tonne / year per

Manufacturer / Importer (Not

registered for that use)

General obligation to Register

Substance of Very High Concern (CMRs, PBTs and vPvBs.)

Placed on candidate list for authorisation

Concentration of > 0.1 % weight-by-weight

Obligation to notify the Agency


Title IIITitle III: : Data SharingData Sharing Pre-SIEFPre-SIEF formationformation

Industry pre-registersIndustry pre-registers ECHAECHA makes contact details available on restricted website makes contact details available on restricted website

SIEFSIEF FormationFormation Process led by industryProcess led by industry

Data sharingData sharing Process led by industryProcess led by industry

Joint submissionJoint submission Industry registersIndustry registers Data sent to evaluation (Data sent to evaluation (ECHECHA, MS)A, MS)

Both data sharing and joint submission are obligatory!Both data sharing and joint submission are obligatory!


Joint submissionJoint submission ObligatoryObligatory joint submission joint submission::

information on the hazard properties of the substanceinformation on the hazard properties of the substance classification and labellingclassification and labelling

Voluntary Voluntary joint submissionjoint submission::

Chemical Safety Report (CSR) (for substances >10 t/a)Chemical Safety Report (CSR) (for substances >10 t/a)

Guidance on safe useGuidance on safe use

Individual Individual submissionsubmission:: Identity of manufacturer and substanceIdentity of manufacturer and substance

Identified usesIdentified uses Exposure information (for substances in 1-10t tonnage Exposure information (for substances in 1-10t tonnage

band)band)


Title IV: Information in the supply chain

Supplier shall provide SDS to recipient, where:Substance is hazardous (1272/2008)Substance is PBT or vPvB

SDS shall contain relevant exposure scenario


Title V: Downstream User Implement risk management measures communicated

to him via the Exposure Scenarios (SDS Annex) If he uses the chemical outside the conditions

described in the exposure scenario(s) Inform his supplier of this use to make it an

identified use Alternatively:

Conduct a safety assessment for his own use (and for his downstream uses if he is a supplier)

Implement ES from own safety assessment Report to the Agency

Communicate further down the supply chain if he is supplier


Title VI: Evaluation

Objective To verify lack of adverse effects to human health and the

environment To prevent unnecessary use of animal tests

Two evaluations Dossier evaluation (including test proposals; initiated by registrant,

mandatory) Substance evaluation (initiated by Member State / Commission,

voluntarily)


Title VI: Evaluation

Dossier Evaluation : ECHA Checking compliance of registration dossiers Checking of test proposals Priority to hazardous substances, CMR, resp.

sensitizers, PBT, vPvB Substance evaluation:

MSCA Checking whether there is a need for further

information on a substance


Titles VII: Authorisation

To ensure good functioning of the internal market

While assuring that risks are properly controlled (substitution)

No placing on the market for substance on Annex XIV, unless it is authorised


Titles VII: Authorisation

Only applies to Substances of Very High Concern, once included in Annex XIV: CMR (carcinogenic, mutagenic, toxic for reproduction) PBT/vPvB (persistent, bioaccumulative, toxic) substances of equivalent concern (endocrine disruptors,

others)

Identification of SVHC

Candidate list 15 substances is published http://

echa.europa.eu/chem_data/candidate_list_table_en.asp

)

Priority list for inclusion into Annex XIV

Inclusion in Annex XIV (comitology decision)


SVHC:SVHC: Information RequirementsInformation Requirements Suppliers must provide sufficient information, Suppliers must provide sufficient information,

available to the supplier, to clients to allow the available to the supplier, to clients to allow the safe use of the article including, as a minimum, safe use of the article including, as a minimum, the name of that substance, if:the name of that substance, if:

They have been identified on the candidate listThey have been identified on the candidate list

The substance is present > 0.1% w/wThe substance is present > 0.1% w/w

On request by consumers, suppliers must provide the On request by consumers, suppliers must provide the consumers with the above information within 45 daysconsumers with the above information within 45 days

Obligation starts immediately afterObligation starts immediately after substance was put on substance was put on the candidate list!the candidate list!


Title VIII:Restriction

Only minor changes compared to existing

system (Directive 76/769/EEC)

In addition to “marketing & use”, now also

manufacturing covered


Annex XIV substances CMR, PBT, vPvB,

‘equivalent concern’

Authorisation(also on Annex XIV)

Restriction(Annex XVII)

Applicationby M, I, or DU for limited time

and scopeon basis of CSR,SEA may be used

Application by COM or Member State

on basis of CSR and SEA

Titles VII & VIII Authorisation and Restriction

Substances of Very High Concern

Formal procedure


Title XI: Classification & Labelling Inventory

REACH does NOT include CRITERIA for C&L!!!

It refers to:

Substance Classification Directive 67/548/EEC

Preparation Classification Directive 1999/45/EC

These references are adapted CLP Reg. 1272/2008

But has links to C&L

Registration

Information in the supply chain

C&L Inventory – Title XI; moved to CLP Title V


C’RA

EnforcementAuthorities

CompetentAuthorities

Member States

Forum

Agency

DGENT

DGENV

DGEMP

DG?? Management Board C’SEA

MS Committee

StandingCommittee

Nationalrepresentative

Experts

Secretariat

Manufacturers

Importers

Downstream users

IndustryCommission

Council Title X : ECHA


ECHA ECHA today:

300 staffStarted to manage the

registration and evaluationFirst steps in authorisationGuidance / IT toolsHelpdesk(s)Committees + Forum establishedStakeholder involvement + consultations started

ECHA in future:Up to 450 staffWill have an important role

in authorisation and restriction


Title XIV: Enforcement

Agency hosts Forum for coordinating activities There must be legal basis to sanction non-compliance Penalties must be effective, proportionate and

dissuasive A frequent report should be issued by each MS

Enforcement is national engagement, working on the basis of national legislation!


REACH Annexes ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND

PREPARING CHEMICAL SAFETY REPORTS ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS ANNEX III CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES

BETWEEN 1 AND 10 TONNES ANNEX IV EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN

ACCORDANCE WITH ARTICLE 2(7)(a) ANNEX V EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN

ACCORDANCE WITH ARTICLE 2(7)(b) ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES

MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE

ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE

ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE


REACH Annexes ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES

MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE

ANNEX XI GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X

ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS

ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES

ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION ANNEX XV DOSSIERS ANNEX XVI SOCIO-ECONOMIC ANALYSIS ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE

MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES


Conclusions

Players Shift in responsibility, while authorities keep some ECHA is important

Replacing animal tests

Good: reduce of costs and number of test animals

For major endpoint (# of test animals and costs) no

alternatives (yet)

Lots of validation and guidance needed

Sharing of test results (SIEF) does reduce # and $


Conclusions Exposure scenarios Could potentially lead to thousands of exposure scenarios

per substance… Much more exposure assessors need to be involved

Evaluation Requires different mindset Resources for evaluation dependent on higher

management (within authorities, industry and Commission)


Conclusions C&L Fast, transparent, open to the public Question how harmonisation between registrants will proceed Role enforcement?

Authorisation & Restriction Good procedures:

1st Annex XV 2nd Authorisation [Annex XIV] or Restriction [Annex XVII]

Authorisations Could become very complex Procedure could take a long time


Conclusions

Enforcement / Inspection Success REACH depends on resources (quantity and

quality) at Enforcement


Where to turn for help?

1. Check the legislation (available in all EU languages)

http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML

2. Check the Guidance website http://guidance.echa.europa.eu

3. Check the Frequently Asked Questions on the ECHA website http://echa.europa.eu/reach/faq_en.asp

4. Talk to colleagues, business associations, industry helpdesks

5. Contact national helpdesk (addresses can be found on http://echa.europa.eu/reach/helpdesk/nationalhelp_en.asp )


Further Information

http://echa.europa.eu

http://ec.europa.eu/enterprise/reach/index_en.htm

http://ec.europa.eu/comm/environment/chemicals/reach.htm

http://ecb.jrc.it/REACH/


Thank you!

[email protected]

[email protected]

REACH Regulation Basic requirements

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