1. EUEB special session on hazardous substance verification
Nicholas Dodd, Shane Donatello Candela Vidal-Abarca
15th April 2015, Brussels
Joint Research Centre, Institute for Prospective Technological Studies

2. Aims of the session
To review how verification works in practice for hazardous substances in articles
To summarise how IPTS envisages verification working for three product groups
To identify/narrow any gaps between IPTS perception of what can work and practical issues faced by CBs and applicants
To identify what works/what doesn’t as part of the current approach being applied 2 2

3. Overview of Session Recap of Horizontal Task Force findings
Approach currently being applied
How it was agreed it could be adapted for different products
Verification component
Product case studies
Textiles
Furniture
Electronics (computers, TVs and displays) 2 2

4. EUEB special session on hazardous substance verification
Recap of Horizontal Task Force findings and approach
15th April 2015, Brussels
Joint Research Centre, Institute for Prospective Technological Studies

5. Article 6(6) and 6(7) The overall approach
Extracts from the summary:
‘[Articles 6(6) and 6(7)] have the objective of avoiding the
presence of inherent hazards in the ecolabelled products.’
‘The overall approach proposed retains its basis in the avoidance
of hazards, but where substitutes are not yet available risk and
exposure shall be considered in order to protect consumers.’

6. Article 6(6) and 6(7) The overall approach
Scientific principles based on, as far as possible, consensus
points from comments and discussions.
Mixtures, articles, complex articles
Group substances by function
Reflect substitution potential
Precautionary approach
Prioritise hazard classes
Set concentration limits
Transparent derogations
Trace hazards along life cycle
Complemented by verification to provide assurance to consumers

7. + Six step approach to criteria development Task 1
Product definition and bill of components, materials and substances
Task 2
Screening for restricted substances and hazard classifications
Task 5
Specification of the criteria and derogation conditions +
Task 6
Specification of assessment and verification requirements
Task 3
Product hazard substitution and green chemistry & engineering initiatives
Task 4
Screening and investigation of derogation requests

8. Product definition and bill of materials
Step 1
Product definition and bill of materials
Aim: To build-up a profile of the material and chemical composition of the product and its associated articles, including accessories, parts and consumables, and/or ingredients
1a. Characterise the product
1b. Build up a bill of components, materials and/or substances
1c. Develop an initial understanding of the supply chain
Main question: What is included in the inventory and on which concentration level?

9. Screening of bill of quantities for hazards/restrictions
Step 2
Screening of bill of quantities for hazards/restrictions
Aim: To identify substances from the Candidate List, REACH Annex XIV and existing criteria that are relevant to the product and to screen the bill of quantities for hazard classes.
2a. Priority screening for Article 57 and 59 substances
2b. Screening for hazard classifications
2c. Tracing of ‘hot spots’ along the product life cycle
‘Cut-off thresholds of 0.10% shall be used in general for components of articles and 0.010% for products that are chemical mixtures.’
Main question: What is included in the inventory and on which concentration level?

10. A modular approach to products (1)
Product screening
A modular approach to products (1)
3.1 Product definition and inventory
Aim: To build-up a profile of the material and chemical composition of the product and associated articles, accessories, parts and consumables.
Inclusion of secondary materials such as packaging, consumables and accessories
Grading of inventory according to ability to obtain information from suppliers
Inclusion of residual substances and contaminants in the inventory
Identification of product articles that are in direct contact with the consumer

11. A modular approach to products (2)
Product screening
A modular approach to products (2)
Aim: Allow for adaptation of the approach based on the distinct composition of the product
Identify which components or ingredients are relevant to the product, depending on whether it is a chemical mixture or an article
Carry out a screening according to the proposed modular rules and scope
Where required apply horizontal screening to a mixture or an article: -
Process residues and contaminants remaining on final product
Chemical additives, coatings and treatments
Main question: What is included in the inventory and on which concentration level?

12. A modular approach to products (3)
Product screening
A modular approach to products (3)
Aim: Provide a product screening guide to support the modular approach for components and ingredients
Chemical mixtures
Chemical ingredients
Organic and mineral ingredients
Final product mixture
Articles and their component parts
Homogenous material components/parts
Complex component devices
Connectors, fixtures and adhesives
Consumables
Horizontal screening
Process residues and
contaminants
Chemical additives,
coatings and treatments
Main question: What is included in the inventory and on which concentration level?

13. Hazard substitution and green chemistry
Step 3
Hazard substitution and green chemistry
Aim: To develop a picture of the practical substitution potential as well as the chemical management systems used for production so as to inform the ambition level and derogation needs.
3a. Initial scoping of evidence
3b. Request for substitution evidence from stakeholders
3c. Creation of front runner product hazard profile(s)
Main question: What is included in the inventory and on which concentration level?

14. Screening and investigation of derogation requests
Step 4
Screening and investigation of derogation requests
Aim: To investigate derogation requests for specific materials, substances or groups of substances. This shall be based on the best available knowledge on hazards, function and market status.
4a. Call for derogation requests from stakeholders
4b. Screening and investigation of derogation requests
4c. Check for possible cross-product derogations
4d. Decision-making on derogation requests
Main question: What is included in the inventory and on which concentration level?

15. Rules for differentiated treatment
Hazard listing
Rules for differentiated treatment
Aim: Recognise that hazards are categorised according to their degree of hazardousness and use this as basis for differentiation
Group 1 Hazards subject to complete restriction
Article 57 and Candidate List (SVHC) substances, CMR Cat. 1B and 1B, ELC substances
Combinations with vP + T or vB + T (T=Acute Tox Cat.1/2)
Group 2 Priority hazards for restriction
CMR Cat.2, Acute Tox Cat.1/2, STOT Cat.1, Aquatic Cat.1/2, Allergens Cat.1
Group 3 Hazards to which greater flexibility shall be applied
Aquatic Cat.3/4, Acute Tox Cat.3, STOT Cat.2
Main question: What is included in the inventory and on which concentration level?

16. Rules for differentiated treatment
Enabling better read across to US EPA/Green Screen
Main question: What is included in the inventory and on which concentration level?

17. Specification of the criteria and derogation conditions
Step 5
Specification of the criteria and derogation conditions
Aim: To tailor and specify the criterion and any associated derogation conditions to the findings from Tasks 1-4.
5a. Structuring and formulation of the criterion
- Article 57/59 substance restrictions
- Hazard restrictions
- General restriction list (to control specific hazards)
- Substance and hazard derogations (may reflect alternatives)
- Assessment and verification
5b. Specifying derogations
5c. Setting derogation conditions
Main question: What is included in the inventory and on which concentration level?

18. Specification of verification requirements
Step 6
Specification of verification requirements
Aim: Top tailor and specify the assessment and verification requirements according to the burden of proof and reputational risk identified for the product.
Indicative ‘hierarchy of verification options’
Level 1: Self-declaration
1a. Self-declaration by applicant based on SDS
1b. Self-declaration from sub-suppliers based on SDS
Level 2: Stricter verification
2a. Final product testing e.g. on risk basis
2b. Site visits e.g. on spot check basis
2c. Tailored: workplace, pollution control, BAT, product performance
Main question: What is included in the inventory and on which concentration level?

19. Suggested discussion points
What are the practical issues faced for each distinct type of product and form of verification e.g. SVHC, hazards, chemical restrictions, derogation conditions?
How should the 0.01% (mixtures) and 0.1% (articles) thresholds be applied in practice, contributing to a sum total for a product, and how far along the supply chain?
How should applicants and CBs make decisions on uncertain hazard classifications?
Is there scope to improve/standardise the language and terminology used?
Are derogation conditions a useful/workable/practical tool? 2 2

20. Thank you for your attention
Nicholas Dodd
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