reach regulation basic requirements n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
REACH Regulation Basic requirements PowerPoint Presentation
Download Presentation
REACH Regulation Basic requirements

Loading in 2 Seconds...

play fullscreen
1 / 47

REACH Regulation Basic requirements - PowerPoint PPT Presentation


  • 97 Views
  • Uploaded on

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. Negotiations Before and after proposal of October 2003 13 . 12 . 2005: political agreement

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'REACH Regulation Basic requirements' - shyla


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
reach regulation basic requirements

REACH Regulation Basic requirements

Semira Hajrlahović Mehić, LL.M., B. Sc.

Tatjana Humar-Jurič, M.Sc.

REACH Regulation Basic requirements

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

REACH Regulation Basic requirements

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

Background

REACH Regulation Basic requirements

reach regulation
REACH Regulation
  • REGULATION (EC) No.1907/2006 of the European Parliamenet and of the Council of 18 December 2006concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing CouncilRegulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
  • REACH
    • Registration
    • Evaluation
    • Authorisation of CHemicals

REACH Regulation Basic requirements

some starting points
Different 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 > 10kg pa

Furthermore

Many existing substances not risk assessed

Call for reducing animal tests

Some starting points

 not good for

man and the environment

 Differences not good

for internal market

REACH Regulation Basic requirements

slide6

REACH in a bookshelf

I

II

III

IV

V

VI

VII

VIII

IX

X

XI

XII

XIII

XIV

XV

Titles:

I

II

III

IV

V

VI

VII

VIII

IX

X

XI

XII

XIII

XIV

XV

XVI

XVII

Annexes:

Technical guidance……….

REACH Regulation Basic requirements

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

Who are the players?

REACH Regulation Basic requirements

reach logic
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 Regulation Basic requirements

reach o bjectives
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 Regulation Basic requirements

reach core elements
REACH Core elements
  • Registration of substances ≥ 1 tonne/yr (staggered deadlines)
  • Information in the supply chain
  • Evaluation of some substances by Member States/ECHA
  • Authorisationonly for substances of very high concern
  • Restrictions - the safety net
  • Agency (ECHA) to manage system

REACH Regulation Basic requirements

reach registration e valuation a uthorisation and restriction of ch emicals

Registration

Evaluation

Authorisation

Restrictions

> 1 tonne/yr

> 10 tonnes/yr

+ substances of concern

CMR & PBT & equivalent concern

Substances of concern

REACH.Registration, Evaluation, Authorisation and restriction of CHemicals

REACH Regulation Basic requirements

reach focus
REACH Focus
  • Priorities
    • high volumes (as a proxy for potential risk)
    • greatest concern (substances & uses with highest risk)

REACH Regulation Basic requirements

no data no market
No data, no market
  • Article 5

“ Subject to Articles 6, 7, 21 and 23, substances on their own, inpreparations or in articles shall not be manufactured in theCommunity or placed on the market unless they have beenregistered in accordance with the relevant provisions of thisTitle where this is required”

REACH Regulation Basic requirements

title ii registration
Title II: Registration
  • Manufacturers/Importers
  • Registration for substances ≥ 1 tonne per year
  • Chemical Safety Report (CSR) for all substances ≥ 10 t per year

REACH Regulation Basic requirements

scope of the regulation
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
  • Exemptionsfor certain:
    • Substances
    • Uses of substances
  • Reduced obligations
    • R&D, polymers and intermediates

REACH Regulation Basic requirements

registration aim
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

REACH Regulation Basic requirements

what is registration
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)

REACH Regulation Basic requirements

what is registration1
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

who has to register
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

REACH Regulation Basic requirements

9/18/2014

19

registration exceptions
RegistrationExceptions
  • 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 Regulation Basic requirements

slide21

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 Regulation Basic requirements

reach time table
Reach time table

Pre-registration

REACH entry into force

>1000 tonnes

CMRs ( > 1 tonne)

Very toxsic to aquatic organisms (R50/53) (> 100 tonnes)

100-1000 tonnes

1-100 tonnes

Non phase-in substances

30.11.

2010

31.05.

2013

31.05.

2018

1.06.

2007

1.06.

2008

1.12.

2008

REACH Regulation Basic requirements

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

Substances in Articles (Article 7)

REACH Regulation Basic requirements

title iii data sharing
Title III: Data Sharing
  • Pre-SIEFformation
    • Industry pre-registers
    • ECHA makes contact details available on restricted website
  • SIEFFormation
    • Process led by industry
  • Data sharing
    • Process led by industry
  • Joint submission
    • Industry registers
    • Data sent to evaluation (ECHA, MS)

Both data sharing and joint submission are obligatory!

REACH Regulation Basic requirements

joint submission
Joint submission

Obligatory joint submission:

information on the hazard properties of the substance

classification and labelling

Voluntary joint submission:

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

Guidance on safe use

Individual submission:

Identity of manufacturer and substance

Identified uses

Exposure information (for substances in 1-10t tonnage band)

REACH Regulation Basic requirements

9/18/2014

25

title iv information in the supply chain
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

REACH Regulation Basic requirements

title v downstream user
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

REACH Regulation Basic requirements

title vi evaluation
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)

REACH Regulation Basic requirements

title vi evaluation1
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

REACH Regulation Basic requirements

titles vii authorisation
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

REACH Regulation Basic requirements

titles vii authorisation1
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 list15 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)

REACH Regulation Basic requirements

svhc information requirements
SVHC:Information Requirements

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

They have been identified on the candidate list

The substance is present > 0.1% w/w

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

Obligation starts immediately aftersubstance was put on the candidate list!

REACH Regulation Basic requirements

9/18/2014

32

title viii restriction
Title VIII:Restriction
  • Only minor changes compared to existing system (Directive 76/769/EEC)
  • In addition to “marketing & use”, now also manufacturing covered

REACH Regulation Basic requirements

titles vii viii authorisation and restriction
Titles VII & VIII Authorisation and Restriction

Formal procedure

Substances of Very High Concern

Annex XIV substances

CMR, PBT, vPvB,

‘equivalent concern’

Application by

COM or Member State

on basis of CSR and SEA

Application

by M, I, or DU

for limited time

and scope

on basis of CSR,

SEA may be used

Authorisation

(also on Annex XIV)

Restriction

(Annex XVII)

REACH Regulation Basic requirements

title xi classification labelling inventory
Title XI: Classification & LabellingInventory

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

REACH Regulation Basic requirements

title x ec h a

DG??

DGEMP

DGENT

DGENV

Council

Title X : ECHA

Commission

Agency

C’RA

Industry

Management

Board

C’SEA

Downstream users

Secretariat

MS Committee

Forum

Manufacturers

Importers

Standing

Committee

Enforcement

Authorities

National

representative

Competent

Authorities

Experts

Member States

REACH Regulation Basic requirements

slide37
ECHA

ECHA today:

 300 staff

Started to manage the registration and evaluation

First steps in authorisation

Guidance / IT tools

Helpdesk(s)

Committees + Forum established

Stakeholder involvement + consultations started

ECHA in future:

Up to 450 staff

Will have an important role in authorisation and restriction

REACH Regulation Basic requirements

title xiv enforcement
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 Regulation Basic requirements

reach annexes
REACH Annexes
  • ANNEX IGENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
  • ANNEX IIGUIDE TO THE COMPILATION OF SAFETY DATA SHEETS
  • ANNEX IIICRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
  • ANNEX IVEXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)
  • ANNEX VEXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)
  • ANNEX VIINFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
  • ANNEX VIISTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE
  • ANNEX VIIISTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE
  • ANNEX IXSTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE

REACH Regulation Basic requirements

reach annexes1
REACH Annexes
  • ANNEX XSTANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE
  • ANNEX XIGENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X
  • ANNEX XIIGENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS
  • ANNEX XIIICRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES
  • ANNEX XIVLIST OF SUBSTANCES SUBJECT TO AUTHORISATION
  • ANNEX XVDOSSIERS
  • ANNEX XVISOCIO-ECONOMIC ANALYSIS
  • ANNEX XVIIRESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES

REACH Regulation Basic requirements

conclusions
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 $

REACH Regulation Basic requirements

conclusions1
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)

REACH Regulation Basic requirements

conclusions2
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

REACH Regulation Basic requirements

conclusions3
Conclusions

Enforcement / Inspection

  • Success REACH depends on resources (quantity and quality) at Enforcement

REACH Regulation Basic requirements

where to turn for help
Where to turn for help?

Check the legislation (available in all EU languages)

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

Check the Guidance websitehttp://guidance.echa.europa.eu

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

Talk to colleagues, business associations, industry helpdesks

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

REACH Regulation Basic requirements

9/18/2014

45

further information
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/

REACH Regulation Basic requirements

thank you

Thank you!

Semira.Mehic@gov.si

Tatjana.Humar-Juric@gov.si

REACH Regulation Basic requirements