Fit for Purpose Application for PROCESS CHEMICALS

Feique– ARP – Process Chemicals Survey July 2015

REACH AUTHORISATION APPLICATION

Fit for purpose application for PROCESS CHEMICALS

I. Introduction

The REACH authorisation process requires from the applicant to submit a full application dossier containing a Chemical Safety Report (CSR), an Analysis of Alternatives (AoA) (with a Substitution Plan (SP) if relevant) and a Socio Economic Analysis (SEA).

There is no limit set for the quantity of information needed; however for the REACH regulators the quality of the information is much more relevant than the quantity.

To try to limit the extent of this heavy workload of gathering information, industry together with authorities is currently looking at what information could be used to create a fit for purpose application dossier. This would provide ECHA with the key information that it needs to assess the application without undue burden on the applicant.

The challenge in this exercise is to find a balance between the information to be provided (type, quality, and quantity) and the information that is necessary for the ECHA Committees to be able to develop their opinion.

In this respect a first project has been launched by the German Authorities and Industry on an industrial process using an aprotic solvent under controlled conditions.

This survey is intended to go further and identify other industrial processes and what data would be needed to describe the case to Regulators. It is expected that a limited and focused application process would be developed for substances used in a well-controlled industrial environment with limited, reduced or no exposure to the humans and to the environment.

The development of a fit for purpose application would be based on existing standardised information, supported by (monitoring) data or any other existing regular measurements demonstrating the use of the Annex XIV substance is under very well-controlled conditions.

Survey sent to ARP, RMT, SGM, technical experts.

Timeline

- Survey answers received at latest by 17th of August 2015

- Compilation of responses by end of August/beginning of September

- Discussion ARP ftf meeting 14th September

- Input to ECHA/BAuA/Cefic workshop on 23rd September 2015.

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II. Questionnaire

1. Definition of Process Chemicals

This survey targets chemical processes occurring in an industrial environment where the substance is used under controlled conditions and where the safe use of the substance can be demonstrated.

It concerns mainly substances entering closed or semi-closed system. However, it does not tackle intermediate as meant by REACH in registration dossier. Indeed under REACH authorisation, intermediate are exempted.

2. Process using SVHC substances

2.1 Do you have a process used in an industrial environment? Yes or no.

- If not => you can stop the survey

- If yes,

o What is the name of the industrial process?

o What are the use conditions? Please specify.

2.2 Is this SVHC used in closed or semi closed system? Yes or No

- Please provide a short description of the system

2.3 Do you have any data to control emissions, exposure from that process? Yes or no

2.4 Do you have any risk management measures / operational conditions linked to this process? Yes or no - If yes, please specify.

- How do you describe them?

2.5 Is this specific application already regulated by another legislation? If yes please specify.

- European legislation

- Non EU legislation

- National legislation Page 3 of 5 Feique– ARP – Process Chemicals Survey July 2015

- Regional legislation

- Other – ….

3. Exposure Measurements

3.1 Do you have in your identified process any exposure data already available? – Yes or No

3.2 Do you have any data generated to meet specific legal requirements? – Yes or No

- If yes, which legislation? Please specify.

3.3 Which kind of data do you have?

- Monitoring data

o Worker monitoring

o Installation monitoring

- Quality control data

- Biomonitoring data

- For which purpose do you use the results?

- How the outcome is expressed?

o Specific results (unit)?

o Through an evaluation?

o Statistics?

o Other, please specify.

- Human Health exposure data – which population is covered?

- Environmental exposure data – air, waste, water, soil. Exposure of man via environment.

- Others: …..

3.4 What is the frequency of the measurements?

- Daily, weekly, monthly, annually, etc…

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4. Example of processes meeting these criteria

Are you aware of other kind of processes meeting these criteria? If yes, please specify.

- Processes already described in other legislation

- Processes already controlled by other legislation

Any other (semi)-closed system application? Please specify.

Please duplicate the questionnaire and fill out a new one for each example of process you may have.

Name of Industry

Thank you for your collaboration

Please provide your feedback to [email protected] by 17th August 2015 at latest