Page 1 of 43
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.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 2 of 43
CONTENTS
1
FILLING INSTRUCTIONS................................................................................................. 4
2
QUESTIONNAIRE CONTACT........................................................................................... 5
3
ABOUT YOUR COMPANY AND BUSINESS ...................................................................... 7
3.1
3.2
3.3
3.4
3.5
About your activities..............................................................................................................7
Cross-border operations ........................................................................................................7
Dual use .................................................................................................................................8
Product development and usage timeframe ........................................................................8
Your company size .................................................................................................................8
4
GENERAL QUESTIONS ON REACH AND CLP.................................................................... 9
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
4.15
Your REACH role(s) ................................................................................................................9
Only representative .............................................................................................................10
REACH processes .................................................................................................................10
Summary of REACH challenges............................................................................................11
Economic impact .................................................................................................................11
Obsolescence .......................................................................................................................13
Procurement strategy ..........................................................................................................14
R&D ......................................................................................................................................14
Direct benefits of REACH .....................................................................................................16
Defence exemption (REACH Art. 2(3)).................................................................................17
Enforcement ........................................................................................................................18
Competitiveness ..................................................................................................................18
Offshoring risk .....................................................................................................................19
Level of REACH compliance documentation .......................................................................19
Comparative regulatory burden ..........................................................................................20
5
PROCESS-SPECIFIC QUESTIONS ................................................................................... 20
5.1
5.1.1
5.1.2
5.2
5.3
5.3.1
5.3.2
5.3.3
REACH Registration..............................................................................................................20
Coverage of defence applications .......................................................................................21
Registration 2018.................................................................................................................22
REACH Notification (Articles 7(2) and 33(1)) .......................................................................23
REACH Authorisation ...........................................................................................................24
Contractual requirements for substance use / non-use .....................................................25
Overall experience with REACH authorisation ....................................................................25
Non-defence REACH exemptions from authorisation .........................................................26
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 3 of 43
5.3.4
5.3.5
5.3.6
5.4
5.5
5.6
5.6.1
5.7
5.8
Impact on maintenance activities .......................................................................................26
Commercial obsolescence ...................................................................................................26
Public funding/other support for substitution / related R&D .............................................27
REACH Restriction ................................................................................................................27
CLP and REACH safety data sheets ......................................................................................28
Other relevant EU chemicals and OHS regulations .............................................................29
Indication of relevant EU regulations ..................................................................................29
Impact ..................................................................................................................................30
EU regulatory consistency ...................................................................................................30
6
FURTHER INFORMATION ON IMPACTS AND IMPROVEMENT PROPOSALS TO THE EC .. 31
7
SUBSTANCE-SPECIFIC QUESTIONS............................................................................... 32
7.1
7.2
Preliminary list of substances/groups for EDA REACH study ..............................................32
Further questions on substances/uses you consider as critical ..........................................38
8
LIST OF ACRONYMS .................................................................................................... 39
9
LIST OF DEFINITIONS .................................................................................................. 41
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 4 of 43
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
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 5 of 43
document), while making clear reference between the document attached and the 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.
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 6 of 43
NO ☐
Don’t
know ☐
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 7 of 43
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?
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 8 of 43
YES ☐
NO ☐
If yes, please specify how many and in which countries:
3.3
Dual use
Do you produce products for the defence and civilian
sectors?
YES
NO
☐
☐
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
www.reachlaw.fi
Tick box
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 9 of 43
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)
☐
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
4.1
GENERAL QUESTIONS ON REACH AND CLP
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)
☐
☐
1 See list of definitions in Chapter 9.
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 10 of 43
4.2
Only representative
YES
NO
Not applicable
☐
☐
☐
Are you directly relying on Only Representatives of nonEEA manufacturers or formulators under REACH Article 8
for 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)
☐
☐
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 11 of 43
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, REACHinduced 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.
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)
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 12 of 43
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
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 (€))
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 13 of 43
Yes
No
Have 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:
Don’t Know
☐
☐
☐
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?
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):
☐
Have you raised your prices due to REACH compliance?
4.6
(€)
☐
(€)
☐
(€)
Obsolescence
Yes
☐
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?
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
No
☐
Don’t Know
☐
☐
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 14 of 43
Has this obsolescence resulted in a loss of business?
Yes
☐
No
☐
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
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:
4.8
Don’t know
☐
☐
No
Partly
☐
☐
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….?
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 15 of 43
Yes
Do 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:
Has 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?
No
Don’t know
☐
☐
Yes
No
Don’t know
☐
☐
☐
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.
What level do you see it as appropriate to fund/conduct this R&D:
Company ☐
National ☐
European ☐
Please add any further explanations:
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REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 16 of 43
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:
Have you implemented new Risk Management
Measures as a result of a REACH process
If yes, please provide additional information:
Yes
No
Don’t know
☐
☐
☐
Have you implemented new Environmental
Release Monitoring measures as a result of a
REACH process
If yes, please provide additional information:
☐
☐
☐
Do you believe that the above measures delivered
actual benefits to health, safety and environment?
If YES/NO, please justify your answer:
☐
☐
☐
Yes
Do you consider or have experience that you may re-use ☐
REACH information (e.g. registration data) for compliance
with similar chemicals regulations outside EEA?
No
Don’t know
☐
☐
If YES/NO, please justify your answer:
Yes
Do you consider any other direct benefits that REACH ☐
has brought about?
If yes, please provide additional information:
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
No
☐
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 17 of 43
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 nonconfidential 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 REACH
DEFENCE EXEMPTIONS (2015) creates a workable and
sufficient solution for the defence sector to mitigate REACH
impacts? If not, why?
YES
☐
NO
☐
NOT
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?
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 18 of 43
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 ☐
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?
www.reachlaw.fi
REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 19 of 43
YES (Please specify below, in which area(s)) ☐
NO ☐
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?
YES (Please specify below, in which area(s)) ☐
NO ☐
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
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?
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REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
Page 20 of 43
Do you have any suggestions, in which areas and how the amount and extent of such REACHrelated 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.
5.1
REACH Registration
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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 applications
Can 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 2018
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:
Yes
No
Partly
☐
☐
☐
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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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?
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
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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Do some of your customers or your national law have specific declaration requirements
which are more demanding than the regulation?
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.
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5.3.1 Contractual requirements for substance use / non-use
Yes
Are any of your products dependent on the use of specific SVHC substances to ☐
meet customer requirements?
Is this dependency due to:
Contractual obligation
Necessity in order
performance/quality
to
No
☐
Yes
No
☐
☐
achieve ☐
☐
Please explain:
Yes
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?
No
☐
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
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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
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?
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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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
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?
NO
☐
If yes, could you please specify (e.g., name of the programme/scheme), and whether you take
part in such programme:
YES
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?
NO
☐
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)?
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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:
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:
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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
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
7 See list of acronyms in Chapter 8.
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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.
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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 defencecritical 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.
YES
NO
DON’T KNOW
☐
☐
☐
DEHP, DBP,
ammunition
DIBP, DIPP &
other phthalates
2,4-DNT
ammunition (not much
used anymore)
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
lead compounds ammunition, EEE
(lead, at least 4 components, lead
or 5 lead salts:
batteries
azide, diazide,
monoxide,
styphnate,
tetroxide)
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
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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?
DEFENCE
DUAL
DON’T
USE ONLY
USE
KNOW
☐
☐
☐
DEFENCE
DUAL
DON’T
USE ONLY
USE
KNOW
☐
☐
☐
DEFENCE
DUAL
DON’T
USE ONLY
USE
KNOW
☐
☐
☐
Are you aware of
ongoing R&D
activities for
replacement for
defence
applications?
YES
NO
☐
☐
YES
☐
NO
☐
YES
☐
NO
☐
Page 34 of 43
Substance name Known defence use(s)
Please add any
additional ones with
blue color.
diisocyanates
(IPDI, MCDI…)
ammunition
(crosslinkers of
polymers such as PBHT,
which is essential for
formulating composite
secondary explosives
chromates
corrosion protection in a
(chromium
very wide range of
trioxide,
sectors (airplanes, land
strontium
vehicles, canons,
chromate)
connectors…)
cadmium
corrosion protection,
infrared detectors, NiCd batteries for
airplanes and missiles
nickel salts
corrosion protection
(acetate, sulfate, such as Zn-Ni
sulfamate,
chloride)
cobalt salts
in processes for Nickel
based corrosion
protection
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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.
YES
NO
DON’T KNOW
☐
☐
☐
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?
DEFENCE
DUAL
DON’T
USE ONLY
USE
KNOW
☐
☐
☐
Are you aware of
ongoing R&D
activities for
replacement for
defence
applications?
YES
NO
☐
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
DEFENCE
USE ONLY
☐
DUAL
USE
☐
DON’T
KNOW
☐
YES
☐
NO
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
DEFENCE
USE ONLY
☐
DUAL
USE
☐
DON’T
KNOW
☐
YES
☐
NO
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
DEFENCE
USE ONLY
☐
DUAL
USE
☐
DON’T
KNOW
☐
YES
☐
NO
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
DEFENCE
USE ONLY
☐
DUAL
USE
☐
DON’T
KNOW
☐
YES
☐
NO
☐
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Substance name Known defence use(s)
Please add any
additional ones with
blue color.
1,3propanesultone
Electrolyte fluid of
lithium ion batteries
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.
YES
NO
DON’T KNOW
☐
☐
☐
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?
DEFENCE
DUAL
DON’T
USE ONLY
USE
KNOW
☐
☐
☐
DEFENCE
DUAL
DON’T
USE ONLY
USE
KNOW
☐
☐
☐
YES
☐
NO
☐
DON’T KNOW
☐
adhesive for EEE
component packaging
(varnish for civil &
military PCBs)
boric acid
used e.g. for electrolytic
deposition of metals
such as Ni and SnPb,
used for emergency
stop of nuclear
reactions
diboron trioxide used e.g. as a doping
agent for power
electronic components
gallium arsenide semiconductors
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
DEFENCE
USE ONLY
☐
DUAL
USE
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
indium
phosphide
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
DEFENCE
USE ONLY
☐
DEFENCE
USE ONLY
☐
DEFENCE
USE ONLY
☐
DUAL
USE
☐
DUAL
USE
☐
DUAL
USE
☐
4-Nonylphenol
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Are you aware of
ongoing R&D
activities for
replacement for
defence
applications?
YES
NO
☐
☐
YES
☐
NO
☐
DON’T
KNOW
☐
YES
☐
NO
☐
DON’T
KNOW
☐
DON’T
KNOW
☐
DON’T
KNOW
☐
YES
☐
NO
☐
YES
☐
NO
☐
YES
☐
NO
☐
Page 36 of 43
Substance name Known defence use(s)
Please add any
additional ones with
blue color.
PTZ (lead,
titanium and
zirconium oxide)
hydrazine
essential for sonars
Fighter Jet Emergency
Power Units, launcher
and satellite propulsion
Beryllium & Be
used in a number of
oxides
structural components +
semiconductors + optics
+ nonmagnetic
material...
some petroleum aerial, naval, land…
substances, e.g. propulsion, lubricants
in NATO fuel?
etc.
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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.
YES
NO
DON’T KNOW
☐
☐
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
YES
☐
NO
☐
DON’T KNOW
☐
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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?
DEFENCE
DUAL
DON’T
USE ONLY
USE
KNOW
☐
☐
☐
DEFENCE
DUAL
DON’T
USE ONLY
USE
KNOW
☐
☐
☐
DEFENCE
DUAL
DON’T
USE ONLY
USE
KNOW
☐
☐
☐
DEFENCE
USE ONLY
☐
DUAL
USE
☐
DON’T
KNOW
☐
Are you aware of
ongoing R&D
activities for
replacement for
defence
applications?
YES
NO
☐
☐
YES
☐
NO
☐
YES
☐
NO
☐
YES
☐
NO
☐
Page 37 of 43
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? Is it CRITICAL for your activities? If the use of the substance is
Are you aware of
I.e. to your knowledge it is still
I.e. to your knowledge it is
RELEVANT and CRITICAL for
ongoing R&D
used today in your organisation
difficult to substitute for
your own/supply chain's
activities for
and/or in your supply chain
technical and/or economic
activities: Is the use to your
replacement for
reasons, supply chain or defence knowledge for DEFENCE ONLY defence
system impact.
or DUAL USE?
applications?
INSERT
YES
NO
DON’T KNOW
YES
NO
DON’T KNOW DEFENCE
DUAL
DON’T
YES
NO
SUBSTANCE
USE ONLY
USE
KNOW
☒
☐
☐
☒
☐
☐
☐
☐
NAME/GROUP
☐
☐
☐
and IDENTIFIERS
(EC/CAS Number)
Please add
YES
NO
DON’T KNOW
YES
NO
DON’T KNOW DEFENCE
DUAL
DON’T
YES
NO
additional rows
USE ONLY
USE
KNOW
☒
☐
☐
☒
☐
☐
☐
☐
as needed
☐
☐
☐
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REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
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31.07.2017
Page 38 of 43
7.2
Further 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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REACHLaw Ltd.
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Page 39 of 43
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)
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Page 40 of 43
EU
European Union
F-GAS
Fluorinated greenhouse gases (Regulation (EU) No 517/2014)
Hazmat
Hazardous Materials
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)
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REACHLaw Ltd.
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Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland
7/31/2017
Page 41 of 43
9
TSCA
Toxic Substances Control Act
UN
United Nations
VOC
Volatile Organic Compounds
WEEE
Waste Electrical and Electronic Equipment (Directive 2012/19/EU)
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
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Page 42 of 43
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))
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)
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7/31/2017
Page 43 of 43
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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REACHLaw Ltd.
Vänrikinkuja 3 JK 21
FI-02600 Espoo
Finland
Tel. +358(0) 9 412 3055
Fax: +358(0) 9 412 3049
Email: [email protected]
Business ID: 2052809-9
Municipality: Espoo, Finland