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

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

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

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

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.’

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

+ 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

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?

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?

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

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?

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?

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?

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?

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?

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?

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?

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?

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

Thank you for your attention Nicholas Dodd Tel. +34 954 488 728  e-mail nicholas.dodd@ec.europa.eu Contact -