1. Substitution of substances of high concern
77th CA meeting – 14 March 2018 Reference : CA-March18-Doc th CA meeting

2. Background
Objective of the BPR: ensure a high level of protection for both human and animal health and the environment
BPR mechanisms to identify substances of particular concerns:
Exclusion criteria set out in Article 5(1)
Substitution criteria set out in Article 10
Regulatory consequences:
Approval restricted to 7 or 5 years. Renewal limited to 7 years
Article 19 restricts the making available on the market for use by the general public of BP of concerns for public health
Product containing substance meeting the exclusion criteria are not eligible for UA (Article 42)
The SA procedure encourages the development of substance with a more favorable environmental or human and animal health profile (Chapter 5)

3. Background BPR mechanisms to support substitution
ECHA runs public consultation to identify suitable alternative substances or technologies (Article 10.3).
The eCA shall perform a comparative assessment during the evaluation of BP containing active substance considered as candidate for substitution (Article 23.1).
Under certain conditions, non-approved substance or non-authorized product may be used for the purposes of research and development activities (Article 56).
Longer protection period for data submitted in view of a new AS or the authorization of a BP containing a new AS (Article 60).
Reimbursement of ECHA fees for alternatives to approved active substances fulfilling one of the exclusion criteria (Art 5 – Fees Regulation).
Reduction of ECHA fees for AS approval or BP authorization of an AS which is not or a BP that does not contain an AS which is candidate to substitution (Art 7 – Fees regulation)
Increase of ECHA fees when the AS is candidate for substitution and when a comparative assessment is needed (Annexes I and II – Fees regulation)

4. Problem Insufficient alternatives on the market Human health risks:
For active substance renewal, this may result in a reduction of the availability of efficient products on the market
Human health risks:
Continued exposure of workers to substances of high concerns
Impossibility to address emerging risks
Less products available for the general public
Environmental risks:
Suspected detrimental effects on the marine environment
Risks of increasing resistance to existing BP
Economical risks:
Increased food contamination by pathogens or pests

5. Findings Point out the substitution objective of the BPR
Need to develop alternatives with a more favorable profile
Prioritisation based on:
The percentage of AS under exclusion/substitution compared to the whole set of approved AS for the different PTs
National initiatives on substitution of biocidal active substances
Downstream users concern about the lack of efficient products
Areas of concerns:
Rodenticides (PT 14)
Mosquitoes control products (PT 18)
Antifouling (PT 21)
In-can preservatives (PT 6)
Preservatives used in veterinary in-vitro diagnostics (PT6)
Wood preservatives for railway sleepers and poles (PT8)

6. Initiatives CAs are invited to: The biocide sector is invited to:
Share their views on the list of priorities.
Reflect whether an event on substitution is needed.
Inform the other CAs and the COM about any national initiatives on R&D relating to alternatives to biocidal substances of high concern.
Share the outcomes of such initiatives in future CA meetings.
Inform the COM about any ideas on how to increase cooperation between MSs.
The biocide sector is invited to:
Actively participate in the next EU research program.
Make use of available information on possible marketable alternatives (e.g. CORDIS, LIFE, ECO-Innovation program, COSME).
Inform the COM about their initiatives in relation to substitution possibility to increase cooperation with other Member States.

7. Initiatives DG SANTE intends to:
Support the ECHA strategy on chemical substitution
Encourage the development of partnerships between all actors in the supply chain (e.g. COSME database)
Engage in dialogues with other DGs (ENV, GROW, RTD, AGRI) or EU agencies (EASME, REA) to seek whether additional support could be given to substitution of SHC in BPs.
Determine its future action plan depending on the feedback received