filling instructions - web viewbusiness id : 2052809-9 ... please provide representative answers...

Questionnaire to defence industries

Date: 1 June 2016 Reference: 16.ESI.OP.038: Service Contract “Study on the Impact of REACH and CLP

European Chemical Regulations on the Defence Sector”

Contractor: REACHLaw Ltd Vänrikinkuja 3 JK 21, FI-02600 Espoo, Finland

Customer: European Defence Agency (EDA) Rue des Drapiers 17-23, B-1050 Brussels, Belgium

Objective: EDA has contracted the consultancy REACHLaw Ltd. to carry out a study on the impact of REACH and CLP European Chemical Regulations on the European defence sector, including in comparison with non-EU defence industries with business in EU. Based on the impact assessment practical improvement proposals for REACH and CLP and their current implementation regime will be developed, mainly with view to the upcoming REACH review 2017 by the European Commission. A list of important substances for defence shall be used to illustrate the impacts and improvement proposals. The study will be complemented with issues relating other relevant EU chemicals laws impacting defence such as BPR, POP and ODS.

Why you should respond:

Your input will be useful or even critical, especially if you hold relevant information on impacts (both positive and negative) and specific substances affected, and you have ideas and opinions on the improvement of the current EU chemicals regulatory framework, importantly REACH.

Deadline for your response:

Your timely response is important. Please return the filled questionnaire in WORD format (no hard copy) and any attachments by Thursday, 30 June 2016 at the latest, to [email protected]. For any questions please contact the contractor’s Project Manager Tim BECKER: by email to [email protected] or by mobile: +358 40 773 8143.

www.reachlaw.fiREACHLaw Ltd.Vänrikinkuja 3 JK 21FI-02600 EspooFinland

Tel. +358(0) 9 412 3055Fax: +358(0) 9 412 3049Email: [email protected]

Business ID: 2052809-9Municipality: Espoo, Finland

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mailto:[email protected]


CONTENTS

1 FILLING INSTRUCTIONS..................................................................................................4

2 QUESTIONNAIRE CONTACT............................................................................................5

3 ABOUT YOUR COMPANY AND BUSINESS........................................................................6

3.1 About your activities............................................................................................................63.2 Cross-border operations......................................................................................................63.3 Dual use............................................................................................................................... 73.4 Product development and usage timeframe.......................................................................73.5 Your company size...............................................................................................................7

4 GENERAL QUESTIONS ON REACH AND CLP.....................................................................8

4.1 Your REACH role(s)...............................................................................................................84.2 Only representative.............................................................................................................84.3 REACH processes................................................................................................................. 94.4 Summary of REACH challenges............................................................................................94.5 Economic impact................................................................................................................104.6 Obsolescence.....................................................................................................................124.7 Procurement strategy........................................................................................................124.8 R&D....................................................................................................................................134.9 Direct benefits of REACH...................................................................................................144.10 Defence exemption (REACH Art. 2(3))...............................................................................154.11 Enforcement......................................................................................................................164.12 Competitiveness................................................................................................................ 164.13 Offshoring risk....................................................................................................................174.14 Level of REACH compliance documentation......................................................................184.15 Comparative regulatory burden.........................................................................................18

5 PROCESS-SPECIFIC QUESTIONS.....................................................................................19

5.1 REACH Registration............................................................................................................195.1.1 Coverage of defence applications......................................................................................195.1.2 Registration 2018...............................................................................................................205.2 REACH Notification (Articles 7(2) and 33(1))......................................................................215.3 REACH Authorisation.........................................................................................................225.3.1 Contractual requirements for substance use / non-use....................................................235.3.2 Overall experience with REACH authorisation...................................................................235.3.3 Non-defence REACH exemptions from authorisation........................................................245.3.4 Impact on maintenance activities......................................................................................245.3.5 Commercial obsolescence.................................................................................................245.3.6 Public funding/other support for substitution / related R&D............................................25




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5.4 REACH Restriction..............................................................................................................255.5 CLP and REACH safety data sheets.....................................................................................255.6 Other relevant EU chemicals and OHS regulations............................................................275.6.1 Indication of relevant EU regulations.................................................................................275.7 Impact................................................................................................................................275.8 EU regulatory consistency..................................................................................................28

6 FURTHER INFORMATION ON IMPACTS AND IMPROVEMENT PROPOSALS TO THE EC...29

7 SUBSTANCE-SPECIFIC QUESTIONS................................................................................30

7.1 Preliminary list of substances/groups for EDA REACH study.............................................307.2 Further questions on substances/uses you consider as critical.........................................36

8 LIST OF ACRONYMS......................................................................................................37

9 LIST OF DEFINITIONS....................................................................................................39




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1 FILLING INSTRUCTIONS

Please read the following filling instructions carefully in order to ensure an adequate response and the protection of your confidential/classified information (if any).

This defence industry questionnaire is drafted having the individual companies in mind. Therefore, if you are filling in the questionnaire as an industry association, please provide representative answers for the companies/associations that you represent.

We would like to receive only one (and not multiple) response per stakeholder/organization.

CONFIDENTIAL INFORMATION

The information you provide will be used to summarize the regulatory impacts and identify improvement proposals in an aggregated and neutralized way. If you have information relevant to the objectives of this study that you are willing to share but only with some kind of protection, we are open to signing an NDA with you. Please contact the contractor’s Project Manager: Mr Tim BECKER, Chief EU Compliance Officer, REACHLaw Ltd., [email protected], +358 40 773 8143.

REFERENCES

With your questionnaire answer please provide any supporting documents and links.

If you think that a question has been answered previously, please refer to the relevant answer / document / weblink. In particular, please refer as appropriate to your previous response to the EDA QUESTIONNAIRE FOR INDUSTRY ON REACH DEFENCE RELATED ISSUES 2015.

Of course you may also refer to other sections / answers within this questionnaire, as appropriate.

COMPLETENESS OF RESPONSE

It is understood that the complexities of organisations, supply chains and products may make it difficult or impossible to answer some of the questions (especially pertaining to specific substances or costs).

PLEASE ANSWER AS MANY QUESTIONS AS POSSIBLE WITHIN THE TIME GIVEN.

If for some of the questions you would need more time to answer, please consider sending us a preliminary questionnaire response (so we can start working with it and to prepare interviews if agreed), and the remaining answers afterwards (including during interviews if agreed).

Perhaps the quantity of information necessary for your response may be too much to be included in the questionnaire or be part of other reports and documents. In this case you are invited to provide additional information in separate documents attached to your response (e.g. A4 MS Word document), while making clear reference between the document attached and the




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corresponding question(s) in this survey that it serves to answer. The answer cells in this survey are also automatically extended as you write.

2 QUESTIONNAIRE CONTACT

Organisation name

Contact person name

Title

Email

Phone / mobile

Has your organisation participated in the EDA QUESTIONNAIRE FOR INDUSTRY ON REACH DEFENCE RELATED ISSUES 2015?

YES ☐ If yes, please make references as appropriate when answering this questionnaire, and - if available - attach your answer to the EDA questionnaire as a separate document (not mandatory).

NO ☐

Don’t know ☐

Are you interested in having a bilateral interview / teleconference with the contractor during to supplement your answers to this survey? The foreseen timeframe for these is June 2016.

YES ☐ If yes, please contact the contractor’s Project Manager: Mr Tim BECKER, Chief EU Compliance Officer, REACHLaw Ltd. ([email protected], +358 40 773 8143) as soon as possible.

NO ☐




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Don’t know ☐




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3 ABOUT YOUR COMPANY AND BUSINESS

3.1 About your activities

Could you please provide the following basic information on the business of your company?

Brief executive summary of your activities/business and position in the European defence market

Ownership structure, in particular: Is your company owned fully/partly by an EU Member State? Which one?

What type(s) of defence systems/components (or other supplies) are you producing? Please tick & add a brief description.

Aeronautical systems ☐

Maritime systems ☐

Land systems ☐

Nuclear systems ☐

Munitions ☐

Electronics/IT ☐

Industrial chemicals ☐

Other ☐

3.2 Cross-border operations

Does your company have operations in the defence sector in more than one (1) EEA Member State?

YES ☐ NO ☐

If yes, please specify how many and in which countries:




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3.3 Dual use

YES NO

Do you produce products for the defence and civilian sectors?

☐ ☐

Defence

Civilian

If Yes above, can you estimate the % of your business for each sector?

3.4 Product development and usage timeframe

For the main products that you manufacture for the defence industry (in case you manufacture a large variety, please pick those with the longest lifecycles) what would be a representative average:

Years

Product Development time

Production Time

Expected Production Lifespan

Product Utilisation Time

3.5 Your company size

Size of your company Tick box

a. Micro (<10 employees and annual turnover or annual balance sheet <€2 million) ☐

b. Small (<50 employees and annual turnover or annual balance sheet <€10 million) ☐




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c. Medium (<250 employees and annual turnover <€ 50 million or annual balance sheet <€ 43 million) ☐

d. Large (>250 employees and annual turnover >€ 50 million or annual balance sheet >€ 43 million) ☐

Further comments (if any):

4 GENERAL QUESTIONS ON REACH AND CLP

4.1 Your REACH role(s)

Please indicate each of your REACH role(s):1

EEA Non-EEA

Producer of articles ☐ ☐

Importer of articles ☐

Downstream user of substances/mixtures ☐

Formulator of mixtures ☐ ☐

Manufacturer of substances ☐ ☐

Importer of substances ☐

Only Representative (REACH Article 8) ☐

Other (please specify below) ☐ ☐

4.2 Only representative

YES NO Not applicable

Are you directly relying on Only Representatives of non-EEA manufacturers or formulators under REACH Article 8 for

☐ ☐ ☐

1 See list of definitions in Chapter 9.




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registration/authorisation of substances on their own or in mixtures imported into the EEA?

Please provide further information (if any):

4.3 REACH processes

Could you please list the REACH processes that you have been affected by:

(Please note: If a section is not applicable to your company, please feel free to skip these questions.)

REACH process Own process

Within supply chain and organisation directly affected

Relevant specific questions for this

process

Registration ☐ ☐ Section 5.1

Notification (REACH Art. 7(2)/33) ☐ ☐ Section 5.2

Authorisation (candidate list and Annex XIV)

☐ ☐ Section 5.3

Restrictions (Annex XVII) ☐ ☐ Section 5.4

Other (please specify below) ☐ ☐

4.4 Summary of REACH challenges

Could you please summarize in global terms the challenges already encountered in your organisation to ensure compliance with REACH? Please highlight the most significant challenges / difficulties. [More detailed questions will follow further below.]

Examples: REACH dossiers for registration/authorisation/defence exemption, REACH-induced R&D and replacement activities, substance tracking, supply chain communication, IT, internal REACH administration, need for external consultants, supply chain and procurement management, risk management associated with non-compliance and obsolescence in the upstream supply chain.




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Could you please highlight significant future challenges that you anticipate for your organization/supply chain in terms of REACH? [More detailed questions will follow further below.]

4.5 Economic impact

If available, can you provide an estimate of the overall additional cost of REACH to your company and if possible a breakdown of the cost of various REACH processes (table below):

REACH process €

Overall REACH additional cost

Registration (including any costs related to Evaluation)

Notification (REACH Article 7(2), 33)

Authorisation (candidate list and Annex XIV)

Restrictions (Annex XVII)

Other (please specify below)

REACH is one of many regulations that companies need to comply with as part of their defence




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related activities. We would like to know of its relative importance versus its cost to your company, if known:If it is possible, can you estimate how much, as a %, does REACH compliance take up in terms of your overall monetary cost of regulatory compliance?

%

Do you think that you spend a disproportionate effort for REACH compliance over other regulatory requirements? Please explain your answer:

As a concrete example to be used supporting our recommendations towards the EC, we would like to estimate roughly the total cost so far related to activities for Cr(VI) authorisation in the European defence sector. Are you able to provide a rough estimation for your organization of costs for authorisation applications or defence exemption requests? (in (€))

Are you able to provide a rough estimation for your organization of costs for substitution (R&D and replacement)? (in (€))

Yes No Don’t KnowHave you already tracked any price increases from your suppliers attributable to REACH compliance?

☐ ☐ ☐

If yes, can you provide an average estimate of this cost increase as a result of REACH?

(€)

Do you believe that these prices will increase / further increase in the future due to REACH?

☐ ☐ ☐

Please explain your answer:

Have you raised your prices due to REACH compliance? ☐ ☐ ☐If yes, can you provide an average estimate of this price increase as a result of REACH?

(€)

Have you incurred additional development or R&D costs due to REACH?

☐ ☐ ☐




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If yes, can you provide an estimate of these costs? (€)If yes, can you mention the source of funding for these additional costs? : Additional comments (if any):

4.6 Obsolescence Yes No Don’t Know

Have any substances, mixtures or articles become unavailable for supply to you as a result of one of the REACH processes

☐ ☐ ☐

Has this resulted in some process/product obsolescence in your operations?

☐ ☐

Can you identify the REACH process that has caused this unavailability, e.g. Registration, Authorisation…If Yes to the above, how have you adapted to this unavailability?

Yes No Don’t knowHas this obsolescence resulted in a loss of business? ☐ ☐ ☐If yes, can you give a rough estimate for the impact as a % of your overall turnover?

%

Is obsolescence due to REACH captured by your company’s normal obsolescence management process

☐ ☐ ☐

Additional comments (if any):

4.7 Procurement strategy Yes No Partly

Has REACH had any impact on the selection of your suppliers (e.g. EU vs. non-EU) or your procurement strategy in general?

☐ ☐ ☐

Can you please elaborate below:




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4.8 R&D Yes No Don’t know

Would you say that R&D activities have increased in your organization/supply chain as a result of REACH?

☐ ☐ ☐

Are alternatives being developed for obsolete or soon to be obsolete substances (how often, who pays for, valid for how long / threatened itself by regulation, satisified with performance of substitute,…?Please elaborate:

Please explain how REACH is influencing the type and nature of the R&D being undertaken, i.e. is it positively or negatively affecting innovation in your products; steering the R&D more towards “Green” or “Sustainable” Chemistry, etc….?

Yes No Don’t knowDo you agree that REACH induced obsolescence does not always imply advancement of the state-of-the-art of your products, e.g. has the focus shifted from advancement to maintenance of current technology?

☐ ☐ ☐

Can you please explain your answer:

Yes No Don’t knowHas your companies R&D budget increased to cover REACH related R&D?

☐ ☐ ☐

If Yes, is it possible to provide a rough estimate (%) of this increase?

If no additional R&D budget is available to support REACH induced obsolescence risks, is your company willing to forsake ‘traditional’ R&D in order to liberate funds for REACH related R&D?

Can you explain your answer, citing examples of past cases and potential future ones.




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What level do you see it as appropriate to fund/conduct this R&D:

Company ☐ National ☐ European ☐

Please add any further explanations:

4.9 Direct benefits of REACH

The REACH Regulation was touted as having considerable direct benefits to Health, Safety and Environment; as well as other direct benefits. In this section of the questionnaire we would like to assess your views on this:

For your operations within the EEA: Yes No Don’t knowHave you implemented new Risk Management Measures as a result of a REACH process

☐ ☐ ☐

If yes, please provide additional information:

Have you implemented new Environmental Release Monitoring measures as a result of a REACH process

☐ ☐ ☐


Do you believe that the above measures delivered actual benefits to health, safety and environment?

☐ ☐ ☐

If YES/NO, please justify your answer:

Yes No Don’t know

Do you consider or have experience that you may re-use REACH information (e.g. registration data) for compliance

☐ ☐ ☐




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with similar chemicals regulations outside EEA?

If YES/NO, please justify your answer:

Yes No Do you consider any other direct benefits that REACH has brought about?

☐ ☐


4.10 Defence exemption (REACH Art. 2(3))

According to REACH Article 2(3) “Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a mixture or in an article, where necessary in the interests of defence”. Unlike e.g. under RoHS there is no specific exemption / disapplication, but a case-by-case decision by the Member State (normally the MoD) is required. Defence stakeholders have reported difficulties associated with the use and sufficiency of this exemption possibility, especially in cross-border cases (issue of non-recognition). In 2015 an EDA CODE OF CONDUCT ON REACH DEFENCE EXEMPTIONS (CoC) was therefore agreed by the subscribing Member States. The CoC established a common framework for applying for a defence exemption from a requirement of REACH.

Could you please provide feedback on your/industry/supply chain’s general experience (challenges/drawbacks/benefits) with the use of the REACH defence exemption? Specific non-confidential examples (uses) may be listed. To which of the REACH processes (registration, notification (Article 7, 33), authorisation, restrictions) has it been applied?

In particular: What are the major limitations of using the defence exemption where it could be justified (e.g. obsolescence risk, dual use, effect in chemical supply chain)?

Do you consider that the EDA CODE OF CONDUCT ON YES NO NOT




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REACH DEFENCE EXEMPTIONS (2015) creates a workable and sufficient solution for the defence sector to mitigate REACH impacts? If not, why?

☐ ☐ SURE

☐

Please explain your answer:

Beyond the current defence exemption which has to be granted for each substance and REACH process, do you consider that a specific exemption or disapplication for defence related applications (such as under RoHS) covering all substances would help mitigate the REACH impact?

4.11 Enforcement Yes No Don’t Know

Have you been audited for REACH compliance by a national authority?

☐ ☐ ☐

Where your company is operating in more than one EEA Member State: Were there any difficulties/challenges due to different approaches by different Member States?

☐ ☐ ☐

Can you please elaborate on the problems and briefly suggest how do you think the process could be improved:

4.12 Competitiveness

Do you consider that the REACH Regulation has already impacted on your business in terms of loss of your global competitiveness?

YES (Please specify below, in which area(s)) ☐ NO ☐




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Do you foresee a soon to come specific threat in this regard?

YES (Please specify below) ☐ NO ☐

Do you consider that the REACH Regulation has already impacted on your business in terms of gain of your global competitiveness?


4.13 Offshoring risk

Have your company, or any of your suppliers that you may know of, considered relocation of manufacturing facilities to non-EEA countries due to REACH?

YES ☐ NO ☐

Do you foresee a soon to come specific threat in this regard?

YES (Please specify below) ☐ NO ☐

Are you aware of any past/current examples of relocation to non-EEA countries to continue using the substance?


4.14 Level of REACH compliance documentation

The REACH Regulation may have increased the amount and extent of required compliance documentation to be provided to ECHA (e.g. registration and authorisation dossiers), national




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enforcement authorities (e.g. list of substances manufactured/imported/used and related volumes, exemption documentation) as well as up and down the supply chain (e.g. extended safety data sheets). Sometimes this documentation needs to be available / provided in several languages.

Where do you see the main areas where REACH has significantly increased the level of required compliance documentation in your organization or supply chain?

Do you have any suggestions, in which areas and how the amount and extent of such REACH-related documentation can or should be reduced?

4.15 Comparative regulatory burden

Could you please generally compare the overall regulatory burden due to REACH with non-EEA chemicals regulations that you are affected by (e.g. TSCA if you operate in the US)?

Do you expect that the regulatory burden under these non-EEA chemicals regulations affecting your business is going to increase in the foreseeable future (e.g. TSCA reform)?

YES NO DON’T KNOW

☐ ☐ ☐

If yes, could you please describe in which area and how:

One solution to REACH problems could be stopping all production using SVHC in the EEA and moving production to a non-EEA country. How do you value this possible solution?

5 PROCESS-SPECIFIC QUESTIONS

Please elaborate further on such processes in the following sections. Questions relating to other processes (no involvement) you may decide to skip, unless you have relevant information/comments.




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5.1 REACH Registration

When answering to these questions, please also consider the upcoming final REACH registration deadline of 31 May 2018 for substances, which is expected to affect many SMEs manufacturing / importing substances (on their own or in mixtures) in volumes of 1-100 tonnes per year.

5.1.1 Coverage of defence applicationsCan you please provide some examples of critical substances for your defence activities that have been affected by REACH Registration:

Has your organization registered any substances under REACH as manufacturer/importer or through an only representative? Can you provide examples of such substances?

For some of these specified substances can you provide your experience (positive or negative) in terms of registration costs e.g. in your opinion were they excessive, problems in SIEF, etc.

For some of these specified substances can you provide your experience (positive or negative) in terms of availability , or lack thereof, of a substance after a registration deadline:

How do you ensure that registrations covering your uses are being made in your (upstream) supply chain? (contractual REACH compliance clauses, detailed supplier REACH audit for critical substances, etc.). Have you been generally asked by your upstream supply chain to inform your substance uses or have you communicated them upstream proactively?




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Could you please elaborate on any problems faced during the Registration phases and solutions your company implemented to mitigate these problems.

In particular: Do you have trouble deciding if or how a substance has to be registered2 because of difficulty to apply guidance and legal definitions (e.g. scope of exemptions from registration, intermediate status, article only or combination of article and substance/mixture, …)?

If yes, please specify:

Do you have any suggestions, based on your experiences in the defence industry as to how the registration process could be improved for defence companies:

5.1.2 Registration 2018Yes No Partly

Looking towards the REACH Registration Deadline in 2018 and given that the defence sector is small compared to other industries, have you received assurances that substances critical for your products will be registered and therefore available for your use after the deadline?

☐ ☐ ☐

Please specify:

Do you consider that commercial obsolescence due to withdrawal of non-registered substances will become a business-critical issue for your organization, especially with regards to the upcoming 2018 deadline and many SME companies as potential registrants?

2 Please note that only REACH Manufacturers and Importers of substances on their own or in mixtures may have to register under REACH. REACH Downstream Users are advised to check, whether the substances and mixtures they use have been duly registered. Please see list of definitions in Chapter 9.




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5.2 REACH Notification (Articles 7(2) and 33(1))

Could you please describe the challenges for your organization to determine, whether the products you supply downstream to your EEA customers (in as far as they qualify as “articles” in terms of REACH Article 3(3)) contain candidate list substances reaching or exceeding the relevant thresholds of 0.1% w/w and - for Article 7(2) also - 1 ton per year respectively?

What is the impact of the recent judgment of the EU Court of Justice (Case C-106/14) 3 - “once an article, always an article”, determining 0.1% for each single component article of a complex article instead of the article as a whole?

Have you agreed (or are you developing) a sector declaration standard (process, template(s), tool(s)) for the defence sector or your industrial sector? If yes, with whom (sector industrial association, supply chain, customers…)?

Are you aware of any industry or defence Standards and initiatives to improve the delivery of substance information across the supply chain?4

Do some of your customers or your national law have specific declaration requirements which are more demanding than the regulation?

3 http://curia.europa.eu/juris/document/document.jsf;jsessionid=9ea7d2dc30d5d17a25a482df4777be19b722670fc3ea.e34KaxiLc3qMb40Rch0SaxuTa3f0?text=&docid=167286&pageIndex=0&doclang=EN&mode=req&dir=&occ=first&part=1&cid=1125929 4 E.g. there are initiatives under consideration eg IPC 175X series particularly 1754 and the 2.18k committee https://www.ipc.org/committeedetail.aspx?Committee=2-18K.




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https://www.ipc.org/committeedetail.aspx?Committee=2-18K

http://curia.europa.eu/juris/document/document.jsf;jsessionid=9ea7d2dc30d5d17a25a482df4777be19b722670fc3ea.e34KaxiLc3qMb40Rch0SaxuTa3f0?text=&docid=167286&pageIndex=0&doclang=EN&mode=req&dir=&occ=first&part=1&cid=1125929



What are the global constraints and/or benefits?

Do you have any suggestions - based on your experience in the defence industry - as to how the notification provisions / their practical implementation could be improved for defence companies?

5.3 REACH Authorisation

If continued use of an Annex XIV substance is required for technical/economic reasons, the EEA downstream user performing it or his upstream manufacturer, importer or formulator may apply for an authorisation under REACH (unless a REACH exemption applies). The minimum impact of authorisation is therefore the cost of authorisation and the duty to substitute the use of the substance when possible. However, further actual or possible impacts of REACH authorisation on industry (importantly: commercial obsolescence, relocation to non-EU, operational changes) are being reported. The authorisation requirement as is only applies to uses of an Annex XIV substance (on its own or in a mixture) within the EEA, including its incorporation into an article in EEA. It does today not apply to the import of articles containing Annex XIV substances from outside EEA.

5.3.1 Contractual requirements for substance use / non-use

Yes No

Are any of your products dependent on the use of specific SVHC substances to meet customer requirements?

☐ ☐

Yes No

Is this dependency due to: Contractual obligation ☐ ☐




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Necessity in order to achieve performance/quality

☐ ☐

Please explain:

Yes No

Do your customers impose other contractual constraints (e.g. ban or avoid use of certain substances, or notify further) beyond REACH or other chemical regulations legal requirements?

☐ ☐

Please explain:

5.3.2 Overall experience with REACH authorisation Have you participated to the authorisation (listing or application) process for one or more substances?, if yes please comment on your overall experience:

Do you have any suggestions, based on your experience in the defence industry, as to how the REACH authorisation process (listing and application) could be improved for defence companies, over and above the measures already implemented5 or underway6 by the REACH authorities?

5.3.3 Non-defence REACH exemptions from authorisation

Have you experienced any particular challenges with the use of exemptions from authorisation? (e.g. for use in scientific R&D, as intermediate, REACH Article 58(2)). Do you consider that the exemption possibilities are sufficiently clear for industry to rely on it where

5 Such as the PACT/RMOA list of substances of potential concern on the ECHA website: http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/pact 6 Such as the simplification of authorisation applications for low volume uses and legacy spare parts.




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http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/pact

they may apply?

5.3.4 Impact on maintenance activities

Could you please describe the impact of inclusion of a defence-critical substance in the REACH authorisation list (Annex XIV) on your/subcontractors’ maintenance activities?

5.3.5 Commercial obsolescence

Do you consider that inclusion in the REACH authorisation process could pose a commercial obsolescence risk for certain defence-critical substances? Can you list any specific substances that you feel are in risk of falling in that situation?

Could you please describe whether and how the REACH authorisation process has impacted (changed) your prior substance obsolescence mitigation strategies?

5.3.6 Public funding/other support for substitution / related R&D

YES NO

Are you aware of any public funding/other support by your national MoD/government or on EU level for R&D for alternatives to SVHC substances like the ones on the REACH candidate list for authorisation?

☐ ☐

If yes, could you please specify (e.g., name of the programme/scheme), and whether you take




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part in such programme:

YES NO

Do you consider that more funding for R&D for alternatives to SVHC substances like the ones on the REACH candidate list for authorisation should be made available by the EU?

☐ ☐

If yes, possibly under which scheme/programme?

5.4 REACH Restriction

REACH restrictions provide a flexible instrument for the EU Member States and the EC/ECHA to initiate a ban of certain substance uses presenting an EU-wide “unacceptable risk” to health or environment, while exempting other uses or providing for transitional arrangements. It may also be used to ban the import of articles containing Annex XIV substances to EU.

Can you give any example(s), where you could not / cannot use a substance for defence related applications, because it is restricted in REACH Annex XVII? If so, can you describe the impacts of the restriction on your activities (such as replacement activities and cost, operational changes)?

5.5 CLP and REACH safety data sheets

The CLP Regulation complements REACH and its Safety Data Sheet (SDS) provisions with rules for the classification, labelling and packaging of chemical substances and mixtures based on the UN GHS.

The defence sector has voiced a major issue with the application of REACH SDS and CLP labelling rules to military explosives/ammunition. Do you believe that a duty to provide REACH SDSs and CLP labels for military explosives/ammunition adds value in the light of the existing requirements for information from MoDs, military standards etc. about ammunition safety during use, test, trials, etc.?

Please provide your answer and explain it:




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Do you have any experience or knowledge of contradicting classifications your industry is faced with?

Answer:

Could you please outline any further key issues for your organization with regards to CLP compliance, in particular on impacts of harmonised classification, labelling and or packaging on defence products?

Answer:

Are you aware if defence exemptions based on CLP Article 1(4) have been used for CLP rules in your organization/supply chain? If yes, could you please provide further information:

Answer:

Are you aware of any potential new or modified harmonized substance classification within CLP which has been or is anticipated to be subject to strong debate and has lead/may lead to some path through the REACH regulation eventually impacting defence?

If yes, please indicate it hereafter, add the substance to the list below (Chapter 7) and fill in the related information.

5.6 Other relevant EU chemicals and OHS regulations

5.6.1 Indication of relevant EU regulations

Which EU Chemicals / OHS Regulations other than REACH & CLP have directly affected your organization / supply chain?

EU Chemicals Regulation YES




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REGULATION (EU) NO 528/2012 (BPR) ☐

REGULATION (EC) NO 850/2004 (POP) ☐

REGULATION (EC) NO 1005/2009 (ODS) ☐

Other (F-GAS, VOC’s, Mercury, Halons, CAD, CMD, etc.)7

Please specify below

☐

5.7 Impact

Please describe the nature of the impact (compliance/substitution costs, operational changes, impact on system development and maintenance, etc.). [Specific substances / uses impacted may be added to the list below in Chapter 7]

5.8 EU regulatory consistency

Do you believe that any of these more specific EU chemicals laws are inconsistent or create double regulation in comparison with REACH? If yes, please specify.

Do you believe that REACH, BPR, POP and other chemical regulations affecting your organisation are inconsistent with other pieces of non-chemical regulations (e.g. workplace regulation and its constraints (OEL limits vs. DNEL’s under REACH) and objectives? If yes, please specify why.

7 See list of acronyms in Chapter 8.




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6 FURTHER INFORMATION ON IMPACTS AND IMPROVEMENT PROPOSALS TO THE EC

Do you consider that the REACH Regulation and/or its practical implementation has any major flaws? If yes, could you please elaborate further (REACH process, provision, issue):

Please provide any further improvement ideas / other comments, not covered so far, that in your view should be taken into account in the EDA study for transmission to the EC, in order to achieve a “better REACH” for the defence sector, while being consistent with the REACH philosophy to put burden of proof for the safe use of chemicals on industry. The comments may also be of general nature (e.g. quality of ECHA website and guidance documents, REACH helpdesk support, transparency of REACH processes and SVHC identification, collaboration with industry).

Do you have any information (studies, statistics, position papers, etc.) that might be relevant for this study? If so, please provide it with your answer to this survey.

o In particular: We are looking for illustrations (diagrams, flowcharts, etc.) of the complexities of the defence sector vis-à-vis REACH and other regulatory requirements that we could use in the study report to the EC.




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7 SUBSTANCE-SPECIFIC QUESTIONS

7.1 Preliminary list of substances/groups for EDA REACH study

The EDA REACH study will include appropriate practical cases of - actual or potential - SVHC substances or groups thereof at different regulatory stages that are considered as critical for defence applications, in order to illustrate the REACH impact on the defence sector, specific issues and to justify REACH (& CLP) improvement proposals.

Therefore we wish to identify with your support the most critical substances at different regulatory stages, which in your opinion should be part of the study, because their inclusion in REACH Annex XIV (already occurred or potentially in the future) could pose an obsolescence risk for your organization, supply chain or the defence sector as a whole.

The following table containing a preliminary substance list for the present study has been created by the contractor and further extended during the study kick-off meeting at the EDA on 11 May 2016. Your answers to the questions (please tick the appropriate boxes) below will help create the final substance list.

At the end of the preliminary substance list you may also add further substances that are relevant and critical for your organization/supply chain. Alternatively / in addition to this you may also add separate files (such as an excel sheet) listing your defence-critical SVHC substances, uses and applications.




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IMPORTANT NOTE: This preliminary list of substances/groups for the EDA REACH study has been chosen in order to illustrate existing / potential impacts of REACH on defence. The substances are at different regulatory stages, from harmonized CLP classification to granted authorisation. The list does not imply that it would be known or established that all listed substances/groups – if not already done - will actually be included in REACH Annex XIV.

Substance name Known defence use(s) Please add any additional ones with blue color.

Is it RELEVANT for your activities? I.e. to your knowledge it is still used today in your organisation and/or in your supply chain?

Is it CRITICAL for your activities? i.e. to your knowledge it is difficult to substitute for technical and/or economic reasons, supply chain or defence system impact.

If the use of the substance is RELEVANT and CRITICAL for your own/supply chain's activities: Is the use to your knowledge for DEFENCE ONLY or DUAL USE?

Are you aware of ongoing R&D activities for replacement for defence applications?

DEHP, DBP, DIBP, DIPP & other phthalates

ammunition YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

2,4-DNT ammunition (not much used anymore)

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

lead compounds (lead, at least 4 or 5 lead salts: azide, diazide, monoxide, styphnate, tetroxide)

ammunition, EEE components, lead batteries

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐



Is it CRITICAL for your activities? i.e. to your knowledge it is difficult to substitute for technical and/or economic

If the use of the substance is RELEVANT and CRITICAL for your own/supply chain's activities: Is the use to your

Are you aware of ongoing R&D activities for replacement for




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reasons, supply chain or defence system impact.

knowledge for DEFENCE ONLY or DUAL USE?

defence applications?

diisocyanates (IPDI, MCDI…)

ammunition (crosslinkers of polymers such as PBHT, which is essential for formulating composite secondary explosives

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

chromates (chromium trioxide, strontium chromate)

corrosion protection in a very wide range of sectors (airplanes, land vehicles, canons, connectors…)

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

cadmium corrosion protection, infrared detectors, Ni-Cd batteries for airplanes and missiles

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

nickel salts (acetate, sulfate, sulfamate, chloride)

corrosion protection such as Zn-Ni

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

cobalt salts in processes for Nickel based corrosion protection

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐









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1,3-propanesultone

Electrolyte fluid of lithium ion batteries

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

4-Nonylphenol adhesive for EEE component packaging (varnish for civil & military PCBs)

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

boric acid used e.g. for electrolytic deposition of metals such as Ni and SnPb, used for emergency stop of nuclear reactions

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

diboron trioxide used e.g. as a doping agent for power electronic components

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

gallium arsenide semiconductors YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

indium phosphide

EEE components YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐









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PTZ (lead, titanium and zirconium oxide)

essential for sonars YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

hydrazine Fighter Jet Emergency Power Units, launcher and satellite propulsion

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

Beryllium & Be oxides

used in a number of structural components + semiconductors + optics + nonmagnetic material...

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

some petroleum substances, e.g. in NATO fuel?

aerial, naval, land… propulsion, lubricants etc.

YES☐

NO☐

DON’T KNOW ☐

YES☐

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐




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Below you may propose additional substances that are relevant and critical for your organization/supply chain, including in relation to some of the other mentioned regulations, such as BPR, POP, ODS, etc.Substance name Known defence use(s) Is it RELEVANT for your activities?

I.e. to your knowledge it is still used today in your organisation and/or in your supply chain

Is it CRITICAL for your activities? I.e. to your knowledge it is difficult to substitute for technical and/or economic reasons, supply chain or defence system impact.

If the use of the substance is RELEVANT and CRITICAL for your own/supply chain's activities: Is the use to your knowledge for DEFENCE ONLY or DUAL USE?

Are you aware of ongoing R&D activities for replacement for defence applications?

INSERT SUBSTANCE NAME/GROUP and IDENTIFIERS (EC/CAS Number)

YES☒

NO☐

DON’T KNOW ☐

YES☒

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐

Please add additional rows as needed

YES☒

NO☐

DON’T KNOW ☐

YES☒

NO☐

DON’T KNOW☐

DEFENCE USE ONLY

☐

DUAL USE☐

DON’T KNOW☐

YES☐

NO☐




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7.2Further questions on substances/uses you consider as critical

In order to have a better picture of the impact of REACH in the defence sector, and to be able to draw up illustrative substance-level examples in our study, we invite you to provide further details on the substances/groups that your consider most RELEVANT and CRITICAL for your own or supply chain’s activities (according to the substance list above, Section 7.1, and your selections).

Please create a separate answer sheet with table for each substance/group as given below. Alternatively / in addition you may also add separate files on the relevant issues listed below.

Substance name/group (EC/CAS number): Defence use(s):

Could you please explain why continued use of this substance is important for you, your suppliers and/or customers? In particular: How the replacement of this substance/use would affect the use of defence equipment and early replacement of such equipment?

What are the main challenges for your organization/supply chain to ensure continued use under REACH and possible substitution for this substance/group? E.g. lack of R&D funding for substitution, dependence on upstream suppliers/possible commercial obsolescence, …

Could you please summarize past/ongoing/planned activities by you/your supply chain to ensure continued use under REACH (or other relevant EU chemicals regulations, e.g. BPR, POP, ODS) for this substance, such as REACH registration, application for authorisation, defence exemption, etc., and provide rough estimates of costs spent/still to be spent:

Can you please give a brief summary of past/ongoing/planned R&D and replacement activities within your organization/supply chain/coordinated by EDA to substitute this substance/group, if any? Is any public funding available and used for this purpose?

Do you believe that the risk potential from your use of this substance/group to human health and the environment warrants inclusion in the REACH Authorisation List, implying a duty to replace the substance with suitable alternatives? Please explain your answer:

Do you have any further comments regarding the REACH (or other relevant EU regulatory) impact for this substance/group on your own/supply chain’s activities?




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8 LIST OF ACRONYMS

ASD Aerospace and Defence Industries Association of Europe

ASD RIWG ASD REACH Implementation Working Group

BPR Biocidal Products Regulation (Regulation (EC) No 528/2012)

CAD Chemical Agents Directive (Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work)

C&L Classification and Labelling of substances and mixtures

CLH Harmonized Classification and Labelling according to CLP

CLP Classification, Labelling and Packaging of substances and mixtures according to Regulation (EC) No 1272/2008

CMD Carcinogens or Mutagens Directive (Directive 2004/37/EC)

CMR Carcinogenic, Mutagenic, toxic to Reproduction

CoRAP Community Rolling Action Plan

Cr(VI) Hexavalent Chromium

DNEL Derived No-Effect Level

EC European Commission

ECHA European Chemicals Agency

EDA European Defence Agency

EDEM European Defence Equipment Market

EDTIB European Defence Technological and Industrial Base

EEA European Economic Area

EEE Electrical and Electronic Equipment (ROHS)

EU European Union

F-GAS Fluorinated greenhouse gases (Regulation (EU) No 517/2014)

Hazmat Hazardous Materials




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LoI Letter of Intent Framework Agreement Treaty of 27 July 2000 between France, Germany, Italy, Spain, Sweden and UK

M&P Materials and Processes

MoD Ministry of Defence

ODS Ozone Depleting Substances (Regulation (EC) No 1005/2009)

OEL Occupational Exposure Limit

OHS Occupational Health and Safety

OR Only Representative (REACH Article 8)

PACT Public Activities Coordination Tool (maintained by ECHA)

pMS Participating Member State

POP Persistent Organic Pollutants (Regulation (EC) No 850/2004)

REACH Registration, Evaluation, Authorisation and Restriction of Chemicals according to Regulation (EC) No 1907/2006

RMOA Risk Management Option Analysis

RoHS Restriction of the use of certain Hazardous Substances in electrical and electronic equipment (Directive 2011/65/EU)

SDS Safety Data Sheet

SIEF Substance Information Exchange Forum

SoS Security of Supply

SIN Substitute It Now

SVHC Substance of Very High Concern (REACH Article 57)

TSCA Toxic Substances Control Act

UN United Nations

VOC Volatile Organic Compounds

WEEE Waste Electrical and Electronic Equipment (Directive 2012/19/EU)




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9 LIST OF DEFINITIONS

Actors in the supply chain

All manufacturers and/or importers and/or downstream users in a supply chain (REACH Article 3(17)

Annex XIV of REACH List of substances subject to Authorisation

Authorisation under REACH

Decision by the European Commission addressed to the applicant (manufacturer, importer or downstream user) granting him the right to continue use(s) applied for of a substance included in Annex XIV of the REACH Regulation after the sunset date. Each authorisation shall specify a time-limited review period.

Consumer The term is not defined in the REACH Regulation, but referred in various REACH provisions, such as Article 3(13) [“…a consumer is not a downstream user”] and Article 33(2) [Article supplier’s duty to communicate information on substances in articles “on request by a consumer…”]. Consumers do not have obligations under REACH.

Distributor Any natural or legal person established within the Community [EEA], including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties (REACH Article 3(14))

Downstream user Any natural or legal person established within the Community, [EEA] other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. (REACH Article 3(13))

European Economic Area (EEA)

All Member States of the European Union (EU) incl. French Guiana, as well as in Norway, Iceland and Liechtenstein. REACH applies in the EEA territory. Switzerland, Turkey or Russia are not part of the EEA.

Importer Any natural or legal person established within the Community [EEA] who is responsible for import; import means the physical introduction into the customs territory of the Community (REACH Article 3(11) and (10))




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Latest application date The date at least 18 months before the sunset date by which applications must be received by ECHA if the applicant wishes to continue to use the substance or place it on the market after the sunset date; this date is specified in Annex XIV

Manufacturer Any natural or legal person established within the Community [EEA] who manufactures a substance within the Community; ‘manufacturing’ means production or extraction of substances in the natural state (REACH Article 3(9) and (8))

Only Representative A natural or legal person established outside the Community [EEA] who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into the Community [EEA] may by mutual agreement appoint a natural or legal person established in the Community [EEA] to fulfil, as his only representative, the obligations on importers under this Title [Title II: Registration of substances]. The representative shall also comply with all other obligations of importers under this Regulation. (REACH Article 8(1) and (2)1)

Placing on the market Supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market (REACH Article 3(12))

Producer of an article Any natural or legal person who makes or assembles an article within the Community [EEA] (REACH Article 3(4))

SME Small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

Substance of Very High Concern (SVHC)

Substances with certain dangerous properties, which may be included in Annex XIV of REACH (see REACH Article 57)

Sunset date The date from which placing on the market and use of the substance shall be prohibited, unless an authorisation is granted; this date is specified in Annex XIV

Supplier of an article Any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market (REACH Article 3(33)

Use Any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation (REACH Article 3(24))




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