SLIDE 1
Structure of presentation
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- The REACH process
- Registration
- Evaluation
- Authorisation
- Restriction
- Framework assessing authorisations
- ECHA
- NL
Ministry of Infrastructure and Water Management
applications Jan Wijmenga Directorate for Environmental safety and - - PowerPoint PPT Presentation
applications Jan Wijmenga Directorate for Environmental safety and - - PowerPoint PPT Presentation
Dutch framework - assessing authorisation applications Jan Wijmenga Directorate for Environmental safety and Risks Structure of presentation The REACH process o Registration Evaluation Authorisation Restriction o
SLIDE 2
SLIDE 3
SVHC Roadmap
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IT screening Manual screening RMOA Substance evaluation SVHC identification Candidate List Harmonised classification Authorisation Annex XIV entry Restriction Annex XVII entry Other legislation/ actions Compliance check No action
Ministry of Infrastructure and Water Management
SLIDE 4
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Substances of Very High Concern (SVHC)
Criteria article 57 REACH: Carcinogenic or Mutagenic or Reprotoxic cat. 1A or 1B conform CLP regulation Persistent, bioaccumulating and toxic (PBT, Annex XIII), or very Persistent and very Bioaccumulating (vPvB) Equivalent Level of Concern (for example sensitizers, STOT RE, endocrine disrupters, persistent and mobile subst.)
Ministry of Infrastructure and Water Management
SLIDE 5
Objective: 1) substitution and 2) safe use Use of substance in EU is not permitted after ‘sunset date’, unless ➢ authorisation is granted ➢
- r application is submitted in time and no decision
taken yet
- > does not cover (imported) articles, only use in or
placing on market in EU
Exemptions: see http://echa.europa.eu/applying-for-Authorisation
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REACH Annex XIV Authorisations.
Ministry of Infrastructure and Water Management
SLIDE 6
Procedure application of authorisation
6 Ministry of Infrastructure and Water Management
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- 2. Commission draft decision
- 1. Opinions of ECHA committees:
- Risk Assessment Committee (RAC)
- Socio-Economic Analysis Committee (SEAC)
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- 3. Discussion in REACH committee
- 4. Vote and then...
Ministry of Infrastructure and Water Management
SLIDE 8
Ministry of Infrastructure and Water Management
SLIDE 9
Framework for assessing authorisation decisions
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Authorisation can be granted when:
- 1. risks are adequately controlled,
- 2. use is necessary for socio-economic
reasons and no suitable alternatives are available
Ministry of Infrastructure and Water Management
SLIDE 10
Framework for assessing authorisation decisions
A balance between risks and socio-economic benefits
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Risk mitigation
☺☺
measures
SLIDE 11
Exposure / Risk limits
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NL policy Exposure of consumers: no authorisation Risk to workers: adequate control should be demonstrated Example: Remaining cancer risk > 4 * 10-3 No support for authorization, as RAC could not conclude that risk mitigation measures sufficiently reduced risk Risk to environment: case by case assessment.
Ministry of Infrastructure and Water Management
SLIDE 12
Time period granted
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NL follows period proposed in RAC / SEAC opinion, usually 4-7-12 years, unless ➢ Alternatives insufficiently assessed (indication: minority positions in RAC/SEAC) ➢ Authorisation is for non-essential uses
Ministry of Infrastructure and Water Management
SLIDE 13
To take home ➢ DATA! ➢ Exposure assessment, ➢ risk mitigation measures, ➢ alternatives;
➢ Wealth of info available at ECHA’s website: https://echa.europa.eu/applying-for-authorisation
Ministry of Infrastructure and Water Management 13
SLIDE 14
14 14 October 2019 Ministry of Infrastructure and Water Management