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Service contract for technical
assistance to review the existing Member State reporting
questionnaire under Article 117
REACH, including the evaluation and configuration of an
appropriate IT tool for the reporting
Final Report
April 2016
Ref. Ares(2016)2178823 - 10/05/2016
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EUROPEAN COMMISSION
Directorate-General for the Environment
Directorate A – Green Economy
Unit A3 – Chemicals
Contact: Mateo Gallego
E-mail: [email protected]
European Commission
B-1049 Brussels
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EUROPEAN COMMISSION
Directorate-General For the Environment 2016 EUR [Number] EN
Service contract for technical
assistance to review the existing
Member State reporting questionnaire under Article 117
REACH, including the evaluation
and configuration of an appropriate IT tool for the
reporting
Final Report
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The original version of this Final Report was prepared by Claire Dupont, Florent Pelsy and Lise
Oulès for Milieu Ltd. under Contract No 2013/ENV.A.3/667720 with the European Commission,
DG Environment in 2016.
The views expressed herein are those of the consultants alone and do not necessarily represent the
official views of the European Commission.
Milieu Ltd. (Belgium), 112 Chaussée de Charleroi, B-1060, Brussels, tel.: +32 2 514 3601; Fax:
+32 2 514 3603; e-mail: [email protected] ; web address: www.milieu.be
mailto:[email protected]://www.milieu.be/
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LEGAL NOTICE
This document has been prepared for the European Commission however it reflects the views only of the
authors, and the Commission cannot be held responsible for any use which may be made of the information
contained therein.
More information on the European Union is available on the Internet (http://www.europa.eu).
Luxembourg: Publications Office of the European Union, 2016
ISBN: 978-92-79-40742-0
Doi: 10.2838/4122
© European Union, 2016
Europe Direct is a service to help you find answers to your questions about the European Union.
Freephone number (*):
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boxes or hotels may charge you).
http://europa.eu.int/citizensrights/signpost/about/index_en.htm#note1#note1
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Service contract for technical assistance on the Member State reporting questionnaire under Article 117 of REACH
TABLE OF CONTENTS
ABREVIATION USED ......................................................................................... XIII
EXECUTIVE SUMMARY ......................................................................................... XV
INTRODUCTION ................................................................................................. 18
1 Theme 1 information on the CA ........................................................................ 19
1.1 Organisation of CA(s) for the operation of REACH .......................................... 19
1.2 Competences of CA(s) ............................................................................... 21
1.3 Human resources ...................................................................................... 24
1.4 Financial and technical resources ................................................................ 27
2 Theme 2: Information on cooperation and communication with other Member States, the European Chemicals Agency (ECHA) and the Commission ..................... 30
2.1 Communication and collaboration between Member States ............................. 30
2.2 Collaboration between authorities at national level ........................................ 30
2.3 Communication and collaboration with ECHA ................................................ 30
2.4 Communication between Member States and the Commission ......................... 31
3 Theme 3: Operation of the national helpdesk ...................................................... 32
3.1 Structure of the helpdesk ........................................................................... 32
3.2 Staff and financing of the helpdesk .............................................................. 33
3.3 Services offered by the helpdesk ................................................................. 34
3.4 Quality assurance ..................................................................................... 35
3.5 Number of enquiries received by national helpdesks per year .......................... 37
3.6 Cooperation between helpdesks .................................................................. 41
4 Theme 4: Awareness raising activities ............................................................... 42
4.1 Type of awareness raising activities carried out by CAs .................................. 42
4.2 Target audience ....................................................................................... 42
4.3 Effectiveness of awareness raising activities ................................................. 44
4.4 Website ................................................................................................... 45
5 Theme 5: information on the promotion of the development, evaluation and use of alternative test methods .................................................................................. 46
6 Theme 6: Information on the participation in REACH Commission and ECHA expert groups / committees (Forum, REACH Committee, MSC, RAC, SEAC, CARACAL, RNC,
Helpnet) ........................................................................................................ 48
6.1 Forum ..................................................................................................... 48
6.1.1 Effectiveness .................................................................................. 48
6.1.2 Concerns ....................................................................................... 48
6.1.3 Proposals for improvement ............................................................... 49
6.2 REACH Committee .................................................................................... 49
6.2.1 Effectiveness .................................................................................. 49
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Service contract for technical assistance on the Member State reporting questionnaire under Article 117 of REACH
6.2.2 Concerns ....................................................................................... 50
6.2.3 Proposals for improvement ............................................................... 50
6.3 Member States Committee (MSC) ............................................................... 51
6.3.1 Effectiveness .................................................................................. 51
6.3.2 Concerns ....................................................................................... 51
6.3.3 Proposals for improvement ............................................................... 51
6.4 Risk Assessment Committee (RAC) .............................................................. 52
6.4.1 Effectiveness .................................................................................. 52
6.4.2 Concerns ....................................................................................... 53
6.4.3 Proposals for improvement ............................................................... 53
6.5 Socio-economic Committee (SEAC) ............................................................. 54
6.5.1 Effectiveness .................................................................................. 54
6.5.2 Concerns ....................................................................................... 55
6.5.3 Proposals for improvement ............................................................... 56
6.6 Competent Authorities for REACH and CLP (CARACAL) ................................... 57
6.6.1 Effectiveness .................................................................................. 57
6.6.2 Concerns ....................................................................................... 57
6.6.3 Proposals for improvement ............................................................... 58
6.7 Risk Communication Network (RNC) ............................................................ 58
6.7.1 Effectiveness .................................................................................. 58
6.7.2 Proposals for improvement ............................................................... 59
6.8 HelpNet Committee ................................................................................... 59
6.8.1 Effectiveness .................................................................................. 59
6.8.2 Concerns ....................................................................................... 60
6.8.3 Proposals for improvement ............................................................... 60
7 7: Information on dossiers evaluation and substance evaluation activities .............. 61
7.1 Dossier evaluation .................................................................................... 61
7.1.1 Activities carried out by Member States .............................................. 61
7.1.2 Human resources ............................................................................ 62
7.1.3 Effectiveness of the dossier evaluation process .................................... 62
7.1.4 Follow-up actions ............................................................................ 64
7.2 Substance evaluation ................................................................................ 65
7.2.1 Activities carried out by Member States .............................................. 65
7.2.2 Collaboration with other Member States ............................................. 67
7.2.3 Cooperation between Member States and ECHA .................................. 67
7.2.4 Follow-up actions ............................................................................ 69
7.2.5 Problems encountered in substance evaluation .................................... 70
7.2.6 Human resources ............................................................................ 71
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Service contract for technical assistance on the Member State reporting questionnaire under Article 117 of REACH
7.2.7 Financial resources .......................................................................... 73
8 Theme 8: Annex XV Dossiers (restriction and identification of SVHC) and other points related to identification of SVHC .............................................................. 75
8.1 Annex XV Restriction dossiers ..................................................................... 75
8.1.1 Activities carried out by CAs ............................................................. 75
8.1.2 Human resources ............................................................................ 77
8.1.3 Consultation of enterprises ............................................................... 79
8.2 Annex XV SVHC dossiers............................................................................ 80
8.2.1 Activities carried out by CAs ............................................................. 80
8.2.2 Human resources ............................................................................ 81
8.2.3 Consultation of enterprises ............................................................... 82
8.2.4 Coordination between ECHA and Member States during the implementation of the SVHC Roadmap ............................................... 83
8.2.5 Financial and human resources dedicated to SVHC identification ............ 83
9 Theme 9 and 10: Information of REACH and CLP enforcement activities ................. 84
9.1 Organisation of REACH and CLP enforcement ................................................ 84
9.1.1 National Enforcement Authorities ...................................................... 84
9.1.2 Coordination between NEAs .............................................................. 91
9.1.3 Resources dedicated to enforcement of REACH and CLP ........................ 92
9.2 Enforcement and inspection strategies ......................................................... 94
9.2.1 REACH enforcement strategies .......................................................... 94
9.2.2 REACH inspection strategy ............................................................... 98
9.2.3 CLP enforcement and inspection strategies ....................................... 100
9.3 Training of inspectors .............................................................................. 103
9.4 Sanctions and appeals (REACH and CLP) .................................................... 104
9.5 Difficulties encountered in enforcement ...................................................... 104
9.6 Cooperation between Member States on REACH and CLP .............................. 105
9.7 Enforcement activities ............................................................................. 106
9.7.1 Number of controls ........................................................................ 106
9.7.2 Prioritisation of controls ................................................................. 109
9.7.3 Compliance of dutyholders ............................................................. 124
9.7.4 Enforcement measures .................................................................. 132
10 Theme 11: Information on the effectiveness of REACH on the protection of human health and the environment, and the promotion of alternative methods, and innovation and competition ............................................................................ 137
11 Theme 12: Other issues and recommendations ................................................. 139
Annex 1: Skill available in national helpdesks ....................................................... 141
Annex 2: Number of enquiries per year received by national helpdesks .................... 143
Annex 3: Forum activities considered most relevant to enhance coordination,
cooperation and exchange of information among Member States ......................... 144
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Service contract for technical assistance on the Member State reporting questionnaire under Article 117 of REACH
Annex 4: REACH enforcement activities ............................................................... 147
Annex 4.1: Estimate of the total number of dutyholders who are likely to have duties imposed on them by REACH / Estimate of the number of dutyholders
who are likely to be considered as registrants as defined by REACH ............... 147
Annex 4.2: Number of manufacturers subject to enforcement activities ................ 148
Annex 4.3: Number of only representatives subject to enforcement activities ........ 150
Annex 4.4: Number of distributors subject to enforcement activities .................... 151
Annex 4.5: Number of downstream users subject to enforcement activities ........... 153
Annex 4.6: Number of importers subject to enforcement activities ....................... 155
Annex 4.7: Number of REACH controls prompted by complaints or concerns
received by Enforcing Authorities in relation to alleged contraventions of the REACH Regulation ................................................................................... 157
Annex 4.8: Number of REACH controls prompted by incidents (e.g. accidents such
as poisoning or other dangerous occurrences)............................................. 158
Annex 4.9: Number of REACH controls prompted by monitoring activities ............. 159
Annex 4.10: Number of REACH controls prompted by the results of an inspection .. 160
Annex 4.11: Number of REACH controls addressing registration and number of
cases of non-compliance found ................................................................. 161
Annex 4.13: Number of REACH controls addressing registration and notification of
substances in articles and number of cases of non-compliance found ............. 162
Annex 4.14: Number of REACH controls addressing the obligation of information in
the supply chain and number of cases of non-compliance found .................... 163
Annex 4.15: Number of REACH controls addressing the duty to communicate information on substances in articles and number of cases of non-compliance
found .................................................................................................... 164
Annex 4.16: Number of REACH controls addressing restriction and number of cases
of non-compliance found .......................................................................... 165
Annex 4.17: Number of REACH controls addressing authorisation and number of
cases of non-compliance found ................................................................. 166
Annex 4.18: Number of REACH controls addressing imported goods and number of
cases of non-compliance found ................................................................. 167
Annex 4.19: Number of REACH controls in which resulted no areas of infringement was found .............................................................................................. 168
Annex 4.20: Number of REACH controls which resulted in verbal or written advice . 169
Annex 4.21: Number of REACH controls which resulted in legal proceedings ......... 170
Annex 4.22: Number of REACH controls which resulted in convictions .................. 171
Annex 4.23: Number of REACH controls which resulted in other enforcement actions172
Annex 5: CLP enforcement activities ................................................................... 173
Annex 5.1: Total number of official controls, such as inspections or investigations,
or other enforcement measures carried out by enforcing authorities in which
CLP was covered and/or enforced during the reporting period ....................... 174
Annex 5.2: Estimate of the total number of dutyholders who are likely to have
duties imposed on them by CLP ................................................................ 175
Annex 5.3: Number of manufacturers subject to enforcement activities under CLP . 176
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Service contract for technical assistance on the Member State reporting questionnaire under Article 117 of REACH
Annex 5.4: Number of Distributors subject to enforcement activities under CLP ..... 178
Annex 5.5: Number of downstream users subject to enforcement activities under CLP ...................................................................................................... 180
Annex 5.6: Number of importers subject to enforcement activities under CLP ........ 182
Annex 5.7: Number of CLP controls prompted by complaints or concerns received by enforcing authorities in relation to alleged contraventions of the CLP
Regulation ............................................................................................. 184
Annex 5.8: Number of CLP controls prompted by incidents (e.g. accidents such as
poisoning or other dangerous occurrences)? ............................................... 185
Annex 5.10: Number of CLP controls prompted by Monitoring activities ................ 186
Annex 5.11: Number of CLP controls prompted by the results of an inspection ...... 187
Annex 5.12: Number of CLP controls addressing hazard classification and number of
cases of non-compliance found ................................................................. 188
Annex 5.13: Number of CLP controls addressing hazard communication in the form of labelling and cases of non-compliance found ........................................... 190
Annex 5.14: Number of CLP controls addressing packaging and cases of non-compliance found ................................................................................... 192
Annex 5.15: Number of CLP controls addressing Harmonisation of classification and labelling of substances and cases of non-compliance found ........................... 194
Annex 5.16: Number of CLP controls addressing Notification to the classification and labelling inventory according to Article 40 and cases of non-compliance found . 195
Annex 5.17: Number of CLP controls addressing Other common provisions, such as
the obligation to maintain information and requests for information and cases of non-compliance found .......................................................................... 197
Annex 5.18: Number of CLP controls addressing imported goods and cases of non-compliance found ................................................................................... 198
Annex 5.19: Number of CLP controls addressing other CLP obligations and cases of non-compliance found ............................................................................. 199
Annex 5.20: Number of CLP controls in which no areas of infringement were found 200
Annex 5.21: Number of CLP controls which resulted in verbal or written advice ..... 201
Annex 5.22: Number of CLP controls which resulted in legal proceedings .............. 202
Annex 5.23: Number of CLP controls which resulted in convictions ....................... 203
Annex 5.24: Number of controls which resulted in other enforcement actions ........ 204
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Service contract for technical assistance on the Member State reporting questionnaire under Article 117 of REACH
ABREVIATION USED
BPR Biocidal Products Regulation
CA Competent Authority
CHESAR Chemical Safety Assessment and Reporting tool
CLEEN Chemicals Legislation European Enforcement Network
CLH Harmonised classification and labelling
CLP Regulation No 1272/2008 on classification, labelling and packaging of
substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No
1907/2006
CMR Carcinogenic, mutagenic and toxic for reproduction
CoRAP Community Rolling Action Plan
DAFM Department of Agriculture, Food & the Marine (Ireland)
DECC Department of Energy and Climate Change (United Kingdom)
ECHA European Chemicals Agency
EEA European Economic Area
EPA Environmental Protection Agency
ES Exposure Scenario
EU European Union
FAQ Frequently Asked Questions
FTE Full time equivalent
GHS Globally Harmonised System of Classification and Labelling of Chemicals
HSA Health and Safety Authority (Ireland)
HSE Health and Safety Executive (United Kingdom)
IGAOT General Inspectorate for the Environment and Spatial Planning
(Portugal)
IUCLIDInternational Uniform Chemical Information Database
MSC Member States Committee
NEA National Enforcement Authority
NIEA Northern Ireland Environment Agency
OECD Organisation for Economic Co-operation and Development
OSH Occupational health and safety
PAH Polycyclic aromatic hydrocarbon
PfA Proposal for Amendment
PBT Persistent Bioaccumulative Toxic chemicals
PIC Regulation No 649/2012 concerning the export and import of hazardous
chemicals
POP Persistent organic pollutants
QSAR Quantitative Structure-Activity Relationships
RAC Risk Assessment Committee
RAPEX Rapid Exchange of Information System
REACH Regulation No 1907/2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals
REF REACH-EN-FORCE
REFT Restriction Efficiency Task Force
RiME Risk Management Expert meeting
RIPE REACH Information Portal for Enforcement
RMOA Risk management option analysis
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Service contract for technical assistance on the Member State reporting questionnaire under Article 117 of REACH
RNC Risk Communication Network
SAICM Strategic Approach to International Chemicals Management
SEAC Committee for Socio-economic Analysis
SDS Safety data Sheets
SME Small and Medium Enterprise
SONC Statement of non-compliance
SVHC Substance of very high concern
VOC Volatile organic compounds
WEEE Directive 2012/19/EU on waste electrical and electronic equipment
WG Working group
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April 2016 I XV
EXECUTIVE SUMMARY
This report provides a comparative analysis of the 2015 Member States reporting
questionnaires under Article 117(1) of the REACH Regulation and Article 46 of the CLP Regulation. Member States are required to submit to the European Commission every
5 years a report on the operation of the REACH Regulation in their respective territories, including sections on evaluation and enforcement (Article 117(1) 117 of the
REACH Regulation) and a report on the results of the official controls, and other enforcement measures taken to ensure compliance with the CLP Regulation (Article 46
of the CLP Regulation).
Competent authorities There are 45 REACH Competent Authorities (CA) operating in the 28 EU Member
States and the 3 EEA countries. 6 countries have more than 1 CA. 28 CAs deal with all REACH processes.
44 CAs indicated they are involved in other chemical legislation. A large majority of
them have responsibilities in CLP (39), biocides (30) and PIC (30). In countries where
only 1 CA has been designated, all CAs except 1 (the Netherlands) have some responsibilities on CLP.
CAs are generally satisfied with their level of technical resources, while they consider
their financial and human resources insufficient or limited, which impedes the achievement of all activities required under REACH.
Cooperation and communication between CAs, and with ECHA and the Commission
CAs generally expressed a high level of satisfaction with the cooperation between CAs
at EU and national levels and with the cooperation with ECHA and the Commission.
National helpdesks
In 25 countries, the REACH helpdesk is part of the REACH CA. In the 6 other cases, the helpdesk is part of another Ministry, a public Agency or a public research institute.
In 24 countries, the REACH helpdesk is also responsible for providing assistance to
industry on CLP.
Helpdesks provide a combination of services ranging from online guidance, advice services, newsletter and/or training. The majority of helpdesks receive between 100
and 1000 enquiries per year. Most enquiries related to registration, safety data sheets and CLP labelling. Only 11 countries keep track of the size of enquirers; in these
countries that have reported data, most enquirers were SMEs.
Awareness raising activities All countries – except Czech Republic and Luxembourg – indicated they have carried
out awareness raising activities during the reporting period. Most countries tend to target a broad audience in their activities (consumers, companies in chemical and
downstream sector). Two-thirds of EU/EEA countries have targeted SMEs as a specific group. Most common awareness raising activities include the production of accessible
information content and the organisation of speaking events.
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Alternative test methods
17 countries indicated they have contributed in the past 5 years to EU and/or OECD work on the development and validation of alternative test methods by participating in
relevant committees.
11 countries provided data on the overall public funding on national research and
development of alternative testing, with 6 countries reporting expenditure of more than Euro 100,000 per year, and 2 countries (Germany and the Netherlands) of more
than Euros 1,000,000.
REACH Commission and ECHA expert groups
CAs expressed a high level of satisfaction towards the functioning of the Forum, the REACH Committee, the Member States Committee (MSC), the Risk Assessment
Committee (RAC) and the Helpnet Committee. The Socio-Economic Assessment
Committee (SEAC), CARACAL and the Risk Communication Network (RCN) gathered less positive feedback. Frequent comments, on all Committees, address organisational
issues and working methods, workload, availability of experts and resources. CAs made suggestions for improvements detailed in Theme 6.
Dossier and substance evaluation
15 CAs reported having been involved in dossier evaluation during the reporting period. Most of them considered that the dossier evaluation process had achieved its
objectives, although some concerns have been raised on the poor quality of registration dossiers impeding the evaluation.
23 CAs have been involved in substance evaluation. 36 substances have been
evaluated in 2012, 47 in 2013 and 51 in 2014. Most frequent issues reported by CAs regarding the substance evaluation process are related to the lack of expertise,
capacity and financial resources, and updates of dossiers by registrants during the
twelve-month evaluation period, leading to changes in the evaluation process.
Restriction and SVHC dossiers
9 CAs indicated having been involved in the preparation of Annex XV Restriction Dossiers during the reporting period, sometimes co-prepared with other CAs or with
ECHA. 7 of them have consulted or involved enterprises in the preparation of restriction dossiers.
11 countries reported having been involved in the preparation of Annex XV SVHC dossiers, sometimes co-prepared with other CAs or with ECHA. 7 of them have
consulted or involved enterprises in the preparation of the dossiers. Most CAs (26) considered there is enough coordination between ECHA and CAs in the implementation
of the SVHC Roadmap.
Enforcement
Enforcement authorities
25 CAs indicated that there was more than 1 REACH national enforcement authority (NEA) in their country; these include environmental authorities, authorities responsible
for health, and consumer protection, chemical agencies, labour inspectorates, and customs administrations.
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21 CAs indicated that there was more than 1 CLP NEA in their country. Although the enforcement of CLP can involve different institutions than those enforcing REACH, in
all EU/EEA countries, the lead enforcement authority is the same for REACH and CLP. In 24 countries, REACH NEAs have responsibilities for enforcing other chemical legal
acts such as the Biocidal Product Regulation or PIC.
Enforcement strategies
The majority of EU/EEA countries (21) indicated having already implemented their enforcement strategy. Strategies can be, depending on the country, stand-alone
REACH enforcement strategies, general strategies not only applied in REACH enforcement, or operational documents planning for enforcement actions. All countries
that devised or implemented an enforcement strategy indicated that it is in line with the strategy of the Forum.
Prioritisation of inspections is usually based on risk analysis. Companies are selected
for inspections according to their potential risk of non-compliance, the risks posed by
the substance and the volume of production, and the type of consumer exposed to the end-product. A number of CAs mentioned aligning their priorities on those defined in
Forum enforcement projects (REACH-EN-FORCE). Among Forum activities, CAs considered enforcement project and pilot projects as the most effective cooperation
activities.
26 CAs indicated having an overall strategy for the enforcement of the CLP Regulation. Over half of them indicated that their strategy was the same as the REACH
enforcement strategy, or described very similar elements to their REACH strategy.
Enforcement activities
All CAs provided data on number of official controls, including inspections, investigations, monitoring, or other enforcement measures related to REACH and CLP.
There is, in both cases, a large degree of variation between countries. Some of the variation may be attributed to the different interpretations of which enforcement
measures should be included or different ways of collecting data. In general, data provided by CAs were often incomplete and not consistent.
Data reported by CAs suggest that, during the reporting period, enforcement activities conducted by NEAs concerned mostly distributors and downstream users, and small
and micro companies. Controls were mostly prompted by monitoring activities and results of previous inspections, rather than by incidents and complaints. In addition, a
higher number of REACH enforcement activities addressed information in the supply chain and restrictions, while CLP controls mostly addressed hazard classification and
labelling. Responses from CAs also show that the majority of controls which identified infringement to the two Regulations are resolved prior to legal proceedings.
Sanctions CAs have described a mixture of civil and criminal measures – according to their legal
system –including among others enforcement notices and injunctions to apply remedial measures; withdrawal of products from the market; administrative fines,
criminal sanctions including fines and imprisonment.
Evaluating the impacts of REACH on the environment, human health, competitiveness and innovation
With the exceptions of Latvia and Slovenia, CAs stated that the effects of REACH would be better evaluated at EU level. 3 CAs felt that evaluating effects was necessary
both at EU and national level.
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April 2016 I 18
INTRODUCTION
This report provides a comparative analysis of the 2015 Member States reporting
questionnaires under Article 117 of the REACH Regulation and Article 46 of the CLP
Regulation. Member States are required to submit to the European Commission every 5
years a report on the operation of the REACH Regulation in their respective territories,
including sections on evaluation and enforcement (art. 117 of the REACH Regulation) and
a report on the results of the official controls, and other enforcement measures taken to
ensure compliance with the CLP Regulation (art. 46 of the CLP Regulation).
EU Member States and EEA countries (Iceland, Liechtenstein, and Norway) were asked to
fill in an online questionnaire, using EUsurvey, an internet-based consultation tool. The
questionnaire requested information on a wide range of issues including:
Composition and organisation of the Competent Authority (hereafter abbreviated as
CA);
Co-operation and communication with other Member States, the Agency and the
Commission;
Operation of the national helpdesk;
Awareness-raising activities conducted by CAs
Promotion of alternative test methods
Participation in REACH Commission and ECHA expert groups
Dossier and substance evaluation
Annex XV restriction dossiers and SVHC dossiers
Enforcement of REACH and CLP regulations
The effectiveness of REACH on the protection of health and environment and the
effects of REACH on innovation and competitiveness
EU Member States and EEA countries reported on their enforcement of REACH for the
period 2010-2015 and their enforcement of CLP between 2011 and 2014. The reporting
period for the first CLP report covered the time between the entry into force of the CLP
Regulation (20 January 2009) and the deadline for submission of this report (20 January
2012). However, the data provided by respondents for the year 2011 were not always
fully complete. This is why it was requested again in this report.
This report follows the structure of the questionnaire, and provides an overview of CAs’
responses for each question. Information on enforcement of REACH and CLP has been
combined, as a certain amount of overlap has been identified in CAs’ responses.
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1 Theme 1 information on the CA
1.1 Organisation of CA(s) for the operation of REACH
45 CAs have been appointed by EU/EEA countries. 6 countries have appointed more than
1 CA. Only 1 country reported changes in the organisation of CAs since the last reporting
exercise. In Romania, 4 CAs have been nominated between 2011 and 2013: the Ministry
of Health for implementing REACH regarding health aspects, the Ministry of Labour,
Family, Social protection and Elderly for implementing REACH regarding occupational
health and safety (OSH) aspects, the Ministry of Defence for implementing art.2 (3) of
REACH and establishing national procedure for exemptions, and the Labour Inspection as
enforcement CA with regards to OSH.
Table 1: CA(s) responsible for REACH
Country Number of CA(s)
Name(s) of CA(s)
Austria 1 Federal Ministry of Agriculture, Forestry, Environment and Water Management
Belgium 1 Risk Management of Chemical Substances Unit Department of Product Policy and Chemical Substances DG Environment Federal Public Service Health, Food Chain Safety and Environment
Bulgaria 1 Ministry of Environment and Water
Croatia 1 Ministry of Health
Cyprus 1 Department of Labour Inspection, Ministry of Labour,
Welfare and Social Insurance
Czech Republic 3 Ministry of the Environment
Ministry of Health Ministry of Industry and Trade
Denmark 1 Danish Environmental Protection Agency
Estonia 1 Health Board
Finland 1 Finnish Safety and Chemicals Agency
France 1 Ministry of Ecology, Sustainable Development and Energy,
General Directorate for Risk Prevention CLP: General Directorate for Labour of the French Ministry of Minister of Labour, Employment, Vocational Training
and Social Dialogue.
Germany 2 Federal Ministry for the Environment, Nature
Conservation, Building and Nuclear Safety Federal Institute for Occupational Safety and Health
Greece 1 Ministry of Finance, General Secretariat of Public Revenue,
General Chemical State Laboratory, Directorate of Energy, Industry and Chemical Products
Hungary 1 National Public Health Centre
Iceland 1 The Environment Agency of Iceland
Ireland 3 Health and Safety Authority (HSA) Environmental Protection Agency (EPA)
Department of Agriculture, Food & the Marine (DAFM)
Italy 1 Ministry of Health-DG Health Prevention
Latvia 1 Latvian Environment, Geology and Meteorology Centre
Liechtenstein 1 Office of environment
Lithuania 1 Environmental Protection Agency
Luxembourg 1 Ministry of Environment
Malta 1 The Malta Competition and Consumer Affairs Authority
Netherlands 1 Ministry of Infrastructure and the Environment CLP: Ministry of Health, Welfare and Sport
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Country Number of CA(s)
Name(s) of CA(s)
Norway 1 Norwegian Environment Agency
Poland 1 Bureau for Chemical Substances
Portugal 3 Portuguese Environment Agency
Directorate-General of Health Directorate General of Economic Activities
Romania 7 Ministry of Environment, Waters and Forests National Environmental Protection Agency
Ministry of Health Ministry of Labour, Family, Social Protection and Elderly Ministry of National Defence
National Environmental Guard Romanian Labour Inspection
Slovakia 1 Centre for Chemical Substances and Preparations, Ministry of Economy
Slovenia 1 Chemicals Office of the Republic of Slovenia
Spain 2 Ministry of Health, Social Services and Equality, General Directorate of Public Health, Quality and Innovation
Ministry of Agriculture, Food and Environment – General Deputy for air quality and the environment
Sweden 1 Swedish Chemicals Agency
United Kingdom 1 The Department for Environment, Food and Rural Affairs
(Defra) is the lead government department for REACH in the UK. Defra has the policy lead for REACH in the UK. The Health and Safety Executive hosts the delegated CA role on behalf of the UK Government.
34 CAs indicated they cooperated with other institutions in relation to REACH issues –
mostly in the areas of environment, consumer protection, employment, health and
safety, public health, economy/industry and customs. In 5 countries, the (main) CA has a
formal role of coordination between other CAs and ministries (Austria, Italy, Lithuania,
the Netherlands, and Spain). In Romania, a working group for the collaboration between
CAs has been established.
In 2 cases, the CAs are assisted by agencies or governmental bodies. In the Netherlands,
the Bureau REACH (National Institute for Public Health and the Environment) carries out
major part of the REACH tasks. In France, the French Agency for Food, Environmental
and Occupational Health & Safety (ANSES) recommends priorities for evaluation,
authorisation and restriction, prepares the French dossiers of proposals of restriction,
identification of substances of very high concern and of harmonised classification and
labelling, prepares opinions to be submitted by the French authorities on the dossiers
proposed by other countries, and participates in the Risk Assessment Committee (RAC)
and Socio-Economic Assessment Committee (SEAC).
Appointed CAs for REACH are mainly environmental, health or consumer protection
authorities. 19 CAs (out of 45) are responsible for or have authority from the Ministry
responsible for Environment. The total number of CAs indicated in Figure 1 is greater
than 45 as 9 CAs indicated that their authority derived from more than one source.
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Figure 1: From what part of Government does this part of the CA has authority from? (Question 11)
The Estonian CA has authority from the Ministry responsible for social affairs. In France
and Luxembourg, the CAs have authority from the Ministries responsible for
environment, infrastructures, transports and, in the case of France, energy.
1.2 Competences of CA(s)
28 CAs (out of 45) reported dealing with all REACH processes – evaluation, risk
assessment, registration, restriction, authorisation and helpdesk.
Among the 25 countries which have 1 CA, the authority is responsible for all parts of
REACH in 21 countries. In Belgium, the CA is responsible for all parts of REACH except
the helpdesk, and has additional competences on harmonised classification and labelling
(CLH), nanomaterials, endocrine disruptors, persistent, bioaccumulative and toxic for
reproduction (PBT) substances, read across, REACH and other pieces of legislation. In
Estonia, the CA deals with evaluation; risk assessment; and the helpdesk. In
Luxembourg the CA is responsible for evaluation; risk assessment; restriction and CLP.
Several CAs mentioned they were also responsible for CLP and enforcement. This
information is available in Themes 9 and 10.
In the 6 countries which have more than 1 authorities, the distribution of competence is
as follows:
Table 2: Competences of CAs in countries where there are more than 1 CA
Country Competences of CAs
Czech Republic
The Ministry of Environment is responsible for all parts of REACH The Ministry of health is responsible for risk assessment The Ministry of Industry and Trade is responsible for authorisation and registration
Germany The Ministry of Environment is responsible for evaluation; authorisation restriction The Ministry of Employment has competence in all parts of REACH
Ireland The Health and Safety Authority is responsible for all parts of REACH The Environmental Protection Agency is responsible for authorisation, restriction and
registration The Department of Agriculture, Food & the Marine is responsible for pesticides
Portugal The Environment Agency is responsible for all parts of REACH except the helpdesk
The General Directorate of Health is responsible for all parts of REACH except the helpdesk General Directorate for Economic Activities is responsible for authorisation,
0 5 10 15 20 25
Consumer Protection
Occupational Health and Safety
Other
Economy/Industry
Public health
Environnement
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Country Competences of CAs
restriction, registration and the helpdesk
Romania The Ministry of Environment, the National Environmental Protection Agency and the Ministry of Health are responsible for all parts of REACH
The Ministry of Labour is responsible for risk assessment and restriction
Ministry of National Defence deals with exemptions art.2 (3) of REACH where necessary in the interest of defence National Environmental Guard deals with authorisation, restriction, registration and
enforcement Romanian Labour Inspection has competence in authorisation, restriction and enforcement
Spain The Ministry of Health is responsible for all parts of REACH except the helpdesk, and coordinates enforcement
The Ministry of Agriculture has competence in all parts of REACH
44 CAs indicated they are involved in other chemical legislation1. A large majority of
them have responsibilities in CLP (39), biocides (30) and PIC (30). In countries where
only 1 CA has been designated, all CAs except 1 (the Netherlands) have some
responsibilities on CLP2.
Figure 2: What other chemical legislation are the staff of the REACH CA involved in? (Question 16)
Table 3: what other chemical legislation are the staff of the REACH CA involved in? (per country)
Country Chemical legislation
Austria PIC Regulation; Biocides; CLP; Pesticides; POPs; Other
Belgium PIC Regulation; CLP; POPs; Other (Mercury, PIC, Strategic Approach to
International Chemicals Management (SAICM), Nanomaterials, OECD group on chemicals, endocrine disrupters, PBT)
Bulgaria PIC Regulation; Biocides; CLP; POPs; Other (Detergents, Seveso, Mercury Export Ban Regulation, RoHS)
Croatia PIC Regulation; Biocides; CLP
Cyprus PIC Regulation ;CLP; POPs; Other (Control of VOCs in paints)
Czech Republic Ministry of Environment: CLP; POPs
1 In Romania, 1 of the 7 CA – the Ministry of National Defence – indicated that its staff was not involved in other chemical legislation. 2 The CA is the same for REACH and CLP in all countries, with the exception of France and the Netherlands. Although the French Ministry of Labour is the CA for CLP, the Ministry of Environment
(REACH CA) shares some responsibilities on CLP.
0 5 10 15 20 25 30 35 40 45
Food legislation
Medical devices
Workers Protection legislation
Cosmetics
Pesticides
Other
POPs
PIC Regulation
Biocides
CLP
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Country Chemical legislation
Ministry of health : Biocides; CLP Ministry of Industry and Trade: CLP
Denmark PIC Regulation; Cosmetics; Biocides; CLP; Pesticides; POPs; Other (product
safety, RoHs, toy safety, ozone depleting substance, VOC, national use restriction)
Estonia PIC Regulation; Cosmetics; Medical devices; Biocides; CLP
Finland Cosmetics; CLP; Other (Detergents)
France PIC Regulation; Biocides; CLP; Pesticides; POPs; Other (endocrine disruptors,
nanomaterials)
Germany Ministry of Environment: PIC Regulation; Biocides; Pesticides; POPs
Ministry of Employment: PIC Regulation; Workers Protection legislation; Biocides; CLP; POPs
Greece PIC Regulation; CLP
Hungary PIC Regulation; CLP;POPs
Iceland Cosmetics; Biocides; CLP; Pesticides; POPs; Other (nature and environment legislation)
Ireland Health and Safety Authority: PIC Regulation; Workers Protection legislation; CLP; Other (Detergents, Chemical Agents, Carcinogens/Mutagens, Asbestos,
Seveso, Chemical Weapons, Biological Agents, Dangerous Preparations Directive)
Environmental Protection Agency: POPs; Other (WEEE, batteries, VOC)
Department of Agriculture, Food & the Marine: PIC Regulation; Food legislation; Biocides; CLP; Pesticides; POPs
Italy PIC Regulation; Workers Protection legislation; Biocides; CLP; Pesticides; POPs; Other (Mercury Convention; Detergents; Seveso; End of Waste)
Latvia Biocides; CLP; Other national legislation
Liechtenstein PIC Regulation; Biocides; CLP; Pesticides
Lithuania PIC Regulation; CLP; POPs; Other (National legislation of chemicals; Waste regulation; Exposure assessment of environmental)
Luxembourg PIC Regulation ;Biocides; CLP
Malta PIC Regulation; Cosmetics; Medical devices; Biocides; CLP; Pesticides; POPs
Netherlands PIC Regulation; Biocides; Pesticides; POPs
Norway Biocides; CLP; POPs; Other (Mercury Convention, Stockholm Convention, Transboundary air pollution, International Chemical Management, OECD groups on chemicals, REACH, Biocides, GHS, Product Registers, Enforcement, Exposure, Test methods - OSPAR Hazardous Chemicals Group)
Poland PIC Regulation; Workers Protection legislation; Cosmetics; Biocides; CLP; Pesticides; POPs; Other (Detergents, Good Laboratory Practice, Drug Precursors
regulation, Tobacco Products, safety of toys, explosives precursors, GHS)
Portugal Environment Agency: PIC Regulation; Biocides; CLP
General Directorate of Health: Biocides; CLP General Directorate for Economic Activities: CLP; Other (Dangerous
Preparations; Aerosols)
Romania Ministry of Environment: PIC Regulation; Biocides; CLP; Other (Detergents) National Environmental Protection Agency: PIC Regulation; Biocides; CLP;
Pesticides; POPs
Ministry of Health: Food legislation; Workers Protection legislation; Cosmetics; Medical devices; Biocides; CLP; Pesticides
The Ministry of Labour: PIC Regulation; Workers Protection legislation; Other
(explosives for civil uses, pyrotechnic articles) National Environmental Guard : PIC Regulation; Biocides; CLP; Pesticides;
POPs; Other (Waste management, Seveso, Market Surveillance, Mercury,
Asbestos, F-Gases, ODS, Detergents, Fertilisers, PCB, Environment legislation)
Slovakia Biocides; CLP; Other (Detergents, aerosol dispensers)
Slovenia PIC Regulation; Cosmetics; Biocides; CLP; POPs; Other (Detergents, Chemical Weapon Convention)
Spain Ministry of Health: CLP Ministry of Agriculture: PIC Regulation; Biocides; CLP; Pesticides; POPs
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Country Chemical legislation
Sweden PIC Regulation ;Biocides; CLP; Pesticides; POPs; Other (Toys directive, RoHS directive, VOC directive, detergents regulation)
United Kingdom PIC Regulation; Biocides; CLP; Pesticides
1.3 Human resources
Table 4 presents the number of staff of the CAs. CAs have reported their staff differently
– number of staff or FTEs. It can be assumed that numbers of staff reported include staff
members working only part-time on REACH. CAs resources vary greatly across countries,
from 1 staff in Liechtenstein to 43 in Italy.
Table 4: Number of staff in CA(s)
Country Number of staff in CA(s)
Austria 20
Belgium 12
Bulgaria 8
Croatia 4
Cyprus 4.5
Czech Republic 3 in the Ministry of Environment; 1 in the Ministry of Health; 2 in the ministry of Industry and Trade
Denmark 20
Estonia 9
Finland 15
France 4.5
Germany 5 in the Ministry of Environment; 30 in the Federal Institute for Occupational Safety and Health
Greece 11
Hungary3 9
Iceland 0.2
Ireland 7.5 FTE in the Health and Safety Authority; 0.2 FTE in the EPA. In addition, there are 27 staff in the Pesticide Registration and Control Divisions (DAFM) whose work may include aspects that cover the
implementation of REACH.
Italy 43
Latvia 4
Liechtenstein 1
Lithuania4 14
Luxembourg5 4
Malta 2
Netherlands 4.5 FTE
Norway 16
Poland 19 FTE
Portugal 5 in the EPA; 3 in the Directorate-General of Health; 4 in the Directorate-General of Economic Activities
Romania 1 in the Ministry of Environment; 3 in the National Environmental Protection Agency; 4 in the ministry of Health; 1 in the ministry of Labour;
2 in the Ministry of National Defence / 204 in the National Environmental Guard; 104 in the Labour Inspection
Slovakia 7
Slovenia 4
Spain 8 in the Ministry of Health, Social Services and Equality; 4 in the Ministry
3 The CA staff includes staff of the REACH Helpdesk, who are involved in the work of the CA when necessary. 4 The number of staff in the Lithuanian Environmental Protection Agency gradually increased from 4 (in 2010) to 14 in the reporting period. 5 The number of staff in Luxembourg increased from 1 to 4 over the reporting period.
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Country Number of staff in CA(s)
of Agriculture, Food and Environment
Sweden 13
United Kingdom 24
Figure 3 presents the staff skills available to all respondent CAs. A large share of CAs
have chemistry expertise – although 10 CAs indicated not having such skills. A significant
proportion lacks exposure assessment and risk assessment skills. However ‘economics
skills’ is the type of skills that CAs most commonly lack – 36 CAs indicated they not
having these skills in-house.
Figure 3: Skills available in CA(S)
Other staff available includes legal advisors (Italy, Sweden), biologist and biomedicine
specialists (Lithuania), biologists (Luxembourg), statisticians (Italy), physicists (Italy),
environment specialist (Latvia).
Most CAs (28 in 20 countries) are satisfied with their in-house level of expertise. CAs
identified a lack of expertise in socio-economic analysis (Belgium, Spain), chemistry and
ecotoxicology (Irish HSA), specific endpoints in toxicology and specific expertise such as
epidemiology (Belgium), evaluation (Romanian EPA), risk communication (Belgium),
exposure assessment, risk assessment and management in particular for endocrine
disruptors (Portuguese EPA). 2 authorities indicated that due to resources constraints,
they have limited specialised staff (Irish HSA and Spain), which in certain cases, reduces
capacity for conducting additional activities such as risk management option analysis
(RMOA) or Annex XV dossier preparation (Estonia).
0
5
10
15
20
25
30
35
40
Nu
mb
er
of
Co
mp
eten
t A
uth
ori
ties
0 0-3 4-6 > 6
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Figure 4: Is the level of expertise of the CA adequate to deal with all requirements under REACH? (Question 14) 6
18 CAs – in 17 countries – indicated that they outsourced part of their work related to
REACH.
Figure 5: EU/EEA countries where at least 1 CA outsources part of its work
Most CAs outsourced scientific expertise to fulfil their duties under REACH during the
reporting period. 5 CAs indicated they outsourced work related to substance evaluation
(Czech Republic, Irish HSA, Latvia, Poland, Portuguese EPA); 1 to restriction dossiers
(Poland)7. 2 CAs mentioned they contracted external expert for the RAC and SEAC work
(Austria and Cyprus). The Irish EPA contracts external to carry-out follow-up inspections
for RAPEX notifications relating to infringement of the REACH Regulation posing a serious
environmental risk. 5 CAs outsourced expertise to research institutes (Hungary, Norway,
Poland, Portuguese EPA, and Slovakia) and 3 to governmental bodies (Denmark,
Slovenia, and the United Kingdom). 2 countries indicated they also contracted private
consultants (the Netherlands and Portuguese EPA) to complete diverse tasks – in
Portugal related to substance evaluation and risk assessment.
6 In Ireland, the HSA and the EPA responded ‘no’ and the department of Agriculture responded ‘yes’; In Romania, 4 CAs out of 7 responded ‘no’. 7 Other CAs have mentioned outsourcing tasks related to substance evaluation and restriction
dossiers (see Table 19 and Table 25)
AT, CZ, DK, EE, FI, FR, DE, EL,
HU, IT, LV, LI, LT, LU, NL, NO, PL,
ES, SE, UK
BE, BG, HR, CY, IS, IE, MT, PT,
RO, SK, SI
Yes No
AT, BE, CY, CZ, DK, HU, IE, LV, NL,
NO, PL, PT, RO, SK, SI, ES,
UK
BG, EE, HR, FI, FR, DE, EL, IS, IT, LI, LT, LU,
MT, SE
Yes No
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Table 5: Expertise outsourced by the CA(s)
Country Expertise outsourced by the CA
Austria Toxicology, risk Assessment, exposure (OSH)
Belgium Specific fields of (eco)toxicology, risk management, endocrine disruptor,
market study
Cyprus Scientific expertise
Czech Republic Substance evaluation in CoRAP
Denmark Toxicological assessments
Ireland (HSA) Environmental exposure assessment, environmental hazard assessment,
physical-chemical hazard assessment, inhalatory toxicology expertise
Ireland (EPA) Follow-up inspections for RAPEX notifications relating to contraventions of the REACH Regulation posing a serious enviornmental risk
Hungary Toxicology, IT expertise
Latvia Toxicologist; ecotoxicologist; occupational safety
Netherlands Methodology development, screening activities, cost analysis, analysis of
alternatives and preparation of classification dossiers
Norway Specific scientific expertise in health and environment
Poland Health, economy, labour and environment issues in the process of substance evaluation; or in the process of data collection in restriction
dossiers
Portugal (EPA) Substance evaluation; risk assessment
Romania (National Environmental Guard)
IT services
Slovenia Toxicology; ecotoxicology
Spain (Ministry of
Agriculture)
Helpdesk
United Kingdom Environmental protection, Ecotoxicology
1.4 Financial and technical resources
CAs are generally satisfied with their level of technical resources. Over half of the CAs
considered that their technical resources are ‘high’. The other half of CAs indicated that
their technical resources are ‘medium’ to ‘low’, which is however largely due to the large
number of Portuguese (3) and Romanian (6) CAs that have expressed a lower level of
satisfaction with their technical resources.
With the notable exception of the UK Health and Safety Executive – ranking their
financial and human resources ‘very high’ – the level of satisfaction of CA with their
financial and human resources is significantly lower. 27 CAs consider their financial
resources ‘low’ to ‘very low’ and 24 their human resources ‘low’ to ‘very low’. Although
the same statistical effect as for technical resources also exist here, it is less significant.
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Figure 6: CAs’ rating of their financial technical and human resources
Table 6: CAs’ rating of their financial, technical and human resources (per country)
8
Country Financial resources Technical resources Human resources Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Malta Netherlands Norway Poland
8 For countries which have more than 1 authority, the rating is calculated as the median rating for
all CAs.
7
8
17
11
19
12
10
17
8
24
1
1
0 5 10 15 20 25 30 35 40 45
Human resources
Technical resources
Financial resources
Number of Competent Authorities
Very low Low Medium High Very high
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Country Financial resources Technical resources Human resources
Portugal Romania Slovakia Slovenia Spain Sweden United Kingdom
Very low Low Medium High Very
High
After rating their financial, technical and human resources, CAs had the possibility to
comment on their responses. Among the 25 countries that have 1 CA, 12 provided a
comment. In addition, 2 CAs in Spain (Ministry of Health and Ministry of Agriculture) and
1 in Romania (National Environmental Guard) provided comments. 9 of them point out
that the lack of resources impedes the achievement of all activities required under
REACH.
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2 Theme 2: Information on cooperation and
communication with other Member States, the
European Chemicals Agency (ECHA) and the
Commission
2.1 Communication and collaboration between Member States
10 respondents expressed satisfaction with the existing collaboration and
communication. (Cyprus, Germany, the Netherlands, Lithuania, Spain, Austria, Denmark,
Bulgaria, Ireland, and Belgium) Many also specifically mentioned that communication
through specific expert groups such as RiME or RIPE had been valuable (Sweden, Cyprus,
and Denmark), and that formal communication channels are functioning well. A number
of respondents felt, however, that the current situation still has room for improvement
(especially Poland). Among most respondents there was also a general wish to promote
further collaboration (e.g. Cyprus, Poland, Portugal, or Croatia). Many expressed a need
for informal communication channels (Finland and Hungary), a facilitated use of IT tools
and online discussion (Latvia, Luxembourg), and for an up-to-date list of contact points
within the CA, (Finland, Poland, the United Kingdom, Hungary, Estonia, Portugal, and
France) in order to facilitate communication between the national CAs. There were also 6
comments calling for more concrete collaboration in the form of joint projects or
laboratory contracts, with a particular regard to the circumstances of small countries
which would benefit from the pooling of resources and expertise (Germany, Iceland,
Slovakia, Estonia, Portugal, and Romania).
2.2 Collaboration between authorities at national level
A large number of respondents perceived the existing collaboration with agencies at the
national level as good. (Sweden, Finland, Norway, Lithuania, Poland, the Netherlands,
the United Kingdom, Austria, Denmark, Croatia, Romania, and France) A number of very
different suggestions for further improvement were mentioned, such as EU-level
harmonisation of procedures, using CAS numbers in the Customs database, granting the
CA access to certain databases used by national enforcement authorities, and joint
trainings. Simply having more regular meetings was also considered as beneficial by 3
CAs (Hungary, Estonia, and Latvia), but at the same time 3 other CAs felt that the
capacity to make further improvements is affected by resource allocation and limited
resources (Portugal, Croatia, and Romania).
2.3 Communication and collaboration with ECHA
15 respondents indicated that the communication and collaboration with ECHA is working
well. (Cyprus, Norway, Greece, Lithuania, Spain, the Netherlands, Slovakia, the United
Kingdom, Austria, Croatia, Italy, Malta, Latvia, Slovenia, and France) Suggestions for
further improvements focused, in particular, on ensuring timely, clear and unambiguous
email communication with ECHA, (Sweden, Poland, Ireland, and Belgium) as well as
identifying specific contact points within ECHA for various issues of interest and/or for
different countries. (Finland, Poland, Spain, Hungary, and Portugal)
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2.4 Communication between Member States and the Commission
Many respondents expressed satisfaction with the existing communication between the
Commission and the CAs (Cyprus, Norway, Lithuania, Slovakia, Austria, Denmark, Italy,
Latvia, and France). At the same time, 2 CAs wished for more and earlier involvement of
the CAs in the policy activities of the Commission (Germany and Spain). There was a
reoccurring request for the Commission to send information and documents sufficiently
far in advance of the contact group meetings (Sweden, Poland, Hungary, Denmark,
Bulgaria, Portugal, Croatia, and Belgium). 3 also suggested that more time dedicated to
meetings and discussion, or allocating some time for pre-discussion prior to meetings,
would be useful (Portugal, Romania, and Italy). 2 respondents suggested that the
Commission should engage in closer cooperation with the individual countries by making
country visits or organising joint events at the national level (Romania and Malta).
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3 Theme 3: Operation of the national helpdesk
3.1 Structure of the helpdesk
In the majority of EU/EEA countries (25), the REACH helpdesk is part of the CA. In the 6
other countries, it can be part of a Ministry – which is not the CA (Belgium and Italy), a
public Agency (Austria and Czech Republic) or public research institute (Luxembourg and
France).
Figure 7: Institutional structure of the Helpdesk in EU/EEA countries
Table 7: Helpdesks separated from the CA
Country Helpdesk
Austria Federal Environment Agency
Belgium Federal Public Service Economy, SMEs, Self-employed and Energy
Czech Republic Czech Environmental Information Agency (CENIA)
France National Institute for Industrial Environment and Risks (INERIS)
Italy Ministry for Economic Development
Luxembourg Luxembourg Institute of Science and Technology
The REACH helpdesk is generally also responsible for providing assistance to industry on
CLP. Ireland and Norway indicated having recently merged the helpdesks for REACH and
CLP to increase the efficiency of the helpdesk (see below).
BG, HR, CY, DK, EE, FI, DE, EL, HU, IS, IE, LV, LI, LT, MT, NL, NO, PL, PT, RO, SK, SI, ES, SE, UK
AT, BE, FR CZ, IT, LU
0 5 10 15 20 25 30
1
Part of Competent Authority Separate independent entity(ies) Other
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Figure 8: Is the same helpdesk used to provide help to industry on CLP? (Question 38)
3.2 Staff and financing of the helpdesk
Figure 9 presents the skills available in EU/EEA countries’ helpdesks. Figures provided by
respondents suggest that some countries might have provided number of staff instead of
FTEs, which could distort the results. Figure 9 shows that most helpdesks have in general
few specialised staff available – apart from chemists, which is the most common
expertise available in helpdesks.
Figure 9: Skills available in helpdesks (FTE)
Other staff includes statisticians (Italy), biomedicine and environment specialists
(Lithuania).
28 helpdesks considered that their level of expertise adequate to respond to all enquiries.
Only 3 helpdesks reported that some expertise is missing (Czech Republic, Ireland, and
Portugal). Czech Republic indicated that the Helpdesk cooperated with experts from the
Ministry of the Environment to compensate gaps. Portugal mentioned legal aspects, IT
tools, and exposure scenarios as missing expertise, and Ireland expertise in chemistry for
substance identification or chemistry specific queries.
AT, BG, HR, CZ, EE, FI, FR, DE,
EL, IS, IE, LV, LI, LT, LU, MT, NO, PL, PT, SK, SI, ES,
SE, UK
BE, CY, DK, IT, HU, NL, RO
Yes No
18 19
5
19 20
26 25 26
21
17
8 10
17
10 9
4 4 4
9 8
2 0 4 1 1 1 2 2 1 4 3 0
5
10
15
20
25
30
Nu
mb
er
of
cou
ntr
ies
0 0 to 1 1 to 2 > 2
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Helpdesks mainly referred enquirers to the ECHA helpdesk for enquiries regarding IT
issues, in particular concerning REACH-IT, IUCLID 5 and CHESAR – 19 helpdesks
mentioned at least 1 of the 3 software or ‘technical IT issues’. 7 helpdesks mentioned
referring to ECHA enquiries from companies based outside the EU (Estonia, Germany,
Hungary, Lithuania, Luxembourg, and Slovakia) or in other EU/EEA countries (Denmark).
Regarding financial resources, only Croatia mentioned that the helpdesk received non-
governmental support.
3.3 Services offered by the helpdesk
All helpdesks have a website, except the helpdesk from Liechtenstein, which provides
support upon request by email. A large number of helpdesks provide a combination of
website, advice services, newsletter and/or training. 5 helpdesks also organise face-to-
face meetings with companies when necessary (Cyprus, Germany, Poland, Slovakia, and
Slovenia) or regular meetings with industry representatives (Belgium). Italy has
established an online support tool for Authorisation and Scaling.
Figure 10: Services offered by the helpdesk
The majority of helpdesks provide at least some of their services (advice services,
training) in English, in addition to their national language. 7 helpdesks (including the
United Kingdom and Ireland) only indicated their national language as working language.
About two-thirds of national REACH helpdesks have provided specific advice to SMEs. 2
of these mentioned that since most of the companies in their country (Finland and
Denmark) were SMEs, they were de facto providing assistance to SMEs, without
specifying how their assistance was adapted to their needs.
0 5 10 15 20 25 30 35
Mediation / conflict resolution
Other
Newsletter
Training
Advice services
Website
Number of Countries
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Figure 11: Do you provide specific advice to SMEs? (Question 44)
Helpdesks were then invited to specify how they were adapting their services to SMEs. 7
helpdesks indicated they have created or tailored written materials (website, leaflet,
newsletter) to be more user-friendly, easy to read and adapted to the specific needs of
SMEs, and 8 have set up specific workshops, seminars or training sessions for SMEs. In
France and Germany, specific actions have been planned in view of the REACH
registration deadline. The German helpdesk has for example produced a ‘Guide to
registration under REACH in 2018’. 2 helpdesks have also provided tools such as a search
engine to find how chemical substances are regulated (Norway) or check-list for
consultants, and templates for letter to supplier/customers for SVHC in articles (France).
6 helpdesks mentioned adapting their answers to SMEs (Austria, Germany, Hungary,
Liechtenstein, the Netherlands, and Spain), to make them ‘more concrete’ (Spain) or
specific. For example, the Hungarian helpdesk draws the attention of the enquirer to
SME-related specificities of REACH (reduced fees, necessity of SME-validation) when
answering enquiries. 5 helpdesk organise face-to-face meetings with SMEs on a need
basis (Austria, Bulgaria, Cyprus, Estonia, and Malta).
3.4 Quality assurance
Helpdesks were asked to describe the helpdesk quality assurance mechanisms. The
ISO9001 standard (setting out the requirements of a quality management system) is in
place in 9 helpdesks. In addition, the Lithuanian Environmental Protection Agency is
currently preparing for the implementation of this standard. 8 helpdesks have explicitly
indicated applying internal quality standards, or standard operating procedures for
responding to enquiries (Finland, Greece, Ireland, Italy, Lithuania, Luxembourg, Poland,
Spain) in replacement or in addition to the ISO standard.
AT, BG, HR, CY, DK, EE, FI, FR, DE, HU, IT, LV, LI, LU, ML,
NL, NO, ES, SE
BE, CZ, EL, IS, IE, LT, PL, PT, RO, SK,
SI, UK
Yes No
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Figure 12: Is ISO9000 norm in place? (Question 41)
13 helpdesks referred to a quality assurance scheme comparable to the four-eye
principle - 2 individuals approve an answer before it can be sent – or peer review,
involving in particular senior members of the helpdesk, experts, or in-house lawyers. In 4
cases, helpdesks have mentioned cooperating with the CA, either to seek feedback from
experts, or to check the helpdesk’s responses (Czech Republic, Finland, the Netherlands,
and the United Kingdom). In the Netherlands, all helpdesk’s responses are checked by
the National Coordinator for quality and consistency. A small number of helpdesks have
made an explicit reference to ECHA guidelines and FAQs (Greece, Iceland, and Slovakia)
and to HelpEx (Iceland and Ireland). 2 helpdesks referred to customer surveys or
surveys after events as main quality assurance mechanism (Bulgaria and Estonia) or
additional source of information (Italy).
14 countries indicated that the national helpdesk seeks feedback on its performance
(Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Italy, Lithuania, Luxembourg, and the Netherlands). Helpdesks have
collected feedback from customers through surveys (Czech Republic, Finland, France,
Greece, Italy, and Lithuania), feedback questionnaires distributed at events (Bulgaria,
France, Germany, Lithuania, Luxembourg) meetings with customers’ representatives
(Finland and the Netherlands), and ad-hoc feedback received through emails (Denmark,
Germany).
25 countries indicated that the national helpdesk reviews its performance and consider
ways to improve its effectiveness (all respondents except Iceland, Liechtenstein, Malta,
Poland, Romania and Slovenia). Measures taken to improve effectiveness generally aim
at increasing the visibility and accessibility of the helpdesk, improving communication
with customers and increase efficiency of internal organisation, especially regarding
response delay. Respondents provided the following examples:
Creating standard responses for common issues and questions to reduce response
delay (Belgium and the United Kingdom);
Creating questions databases / IT tools to improve sorting requests and searching
through questions (Ireland, Sweden)
Introduction of webpage to receive questions and send responses (Slovakia)
Merging the REACH and CLP helpdesks to create a single point of contact for
customers (Ireland and Norway);
Improve websites, factsheets, guidance and communication material to reduce the
number of requests (Austria, Germany, Greece, Norway)
HR, DK, FR, IS, LV, LU, MT, NL, NO, ES,
SE AT, BE, BG, CZ, CY, EE, FI, DE, EL, HU,
IE, IT, LI, LT, PL, PT, RO, SK, SI, UK
Yes No
-
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April 2016 I 37
Focus activities on topics where there is high demand (Germany)
Training staff on specific issues related to REACH and CLP Regulations (Greece)
3.5 Number of enquiries received by national helpdesks per year
The number of enquiries received by national helpdesks varies significantly between
countries. France, Germany, Poland, Sweden and the United Kingdom received over a
thousand enquiries per year; Iceland, Liechtenstein and Slovakia (in the last 3 years)
received less than a hundred requests per year.
Figure 13: How many enquiries does the helpdesk receive per year? (Question 42)
The number of enquiries received by national helpdesks has remained relatively constant
over the reporting period in most countries. Greece has however experienced a
significant increase in the number of enquiries received from 2010 to 2014 (from 1-100
in 2010 to over a thousand in 2014). Answers per countries are available in Annex 2.
Communication between companies and helpdesks is essentially done via emails and
phone.
Figure 14: How are the majority of enquiries received? (Question 43)
All countries except Luxembourg and Poland provided data on the percentage of helpdesk
enquiries related to a closed list of topics proposed in the questionnaire. Figure 15
presents the percentage of enquiries received on average by national helpdesks for each
0
5
10
15
20
25
1 - 100 101 - 1000 > 1000
Nu
mb
er
of
cou
ntr
ies
Number of enquiries recieved per year
0 5 10 15 20 25 30 35
Fax
Letter
Other
Phone
Email
Number of Countries
-
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April 2016 I 38
topic. Cases where helpdesks reported 0% of enquiries received were included in the
average.3 countries whose total percentage of enquiries exceeded significantly 100%
were excluded from the series (Ireland, Malta and Slovenia)9. Greatest number of
enquiries related to registration, safety data sheets and CLP labelling.
Figure 15: Average percentages of enquiries received by national helpdesks on specific topics in the reporting period
Only a third of national helpdesks have kept track of the size of enquirers. Among these,
with the exception of France, large enterprises are generally responsible for a small share
of enquiries, compared to SMEs and micro enterprises. Helpdesks have reported
receiving a higher percentage of enquiries from SMEs. In Cyprus and Estonia, micro-
enterprises sent 90% of enquiries.
Table 8: Company size of enquirers (percentage of total)
Country Large
enterprises
Medium
enterprises
Small
enterprises
Micro
enterprises
Other
Belgium 80-90 80-90
Bulgaria 19.1 23.6 34.83 11.24 11.24
Cyprus 1 1 8 90 0
Estonia 1 2 6 90 1
France 37.3 17.5 24.8 16.4
Greece 12 23 44 21 0
9 Estonia was not excluded although the numbers reported totalled 104.5%.
0 2 4 6 8 10 12 14 16 18 20
Evaluation
Testing
Data sharing
CSR preparation
IUCLID5
SIEFs
REACH-IT
Only representative obligations
Authorisation
Enforcement
CLP Classification and labelling inventory
SVHC
Restriction
CLP Packaging
Obligations regarding articles
Pre-registration
CLP Classification
Downstream user obligations
Other
CLP Labelling
Safety Data Sheets
Registration
Percentage of enquiries recieved
-
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April 2016 I 39
Country Large enterprises
Medium enterprises
Small enterprises
Micro enterprises
Other
Italy 15 20 30 30 5
Malta 10 40 25 25
Netherlands 10 25 25 30 10
Norway 5 35 30 10 20
Slovenia 10 75 5 5 5 Cells were left blank when data were not available.
About half of the helpdesks indicated they received mostly straightforward enquiries, and
the other half, mostly complex enquiries.
Figure 16: Are enquiries received mostly: complex, straightforward, no information?
As shown in Table 9, 7 helpdesks reported receiving at least 70% of complex enquiries.
The perceived complexity of the enquiries received might be related to the fact that 4
these countries reported a limited number of staff available (Austria, Denmark, Ireland,
and Liechtenstein) which suggests a higher workload and potential resources constraints.
Table 9: Proportion of enquiries received considered as ‘complex’ or ‘straightforward’ (percentage)
Country Straightforward Complex
Austria 15 85
Belgium 50 50
Bulgaria 90 10
Croatia 35 65
Cyprus 90 10
Czech Republic 33 67
Denmark 15 85
Estonia 5 95
Finland 95 5
France 40 60
Germany 13 87
Greece 80 20
Hungary 55 45
Iceland 90 10
Ireland 30 70
Italy 60 40
Latvia 65 35
Liechtenstein 30 70
Luxembourg 30 70
Malta 90 10
AT, BE, HR, CZ, DK, EE, DE, FR,
IE, LI, LU, NL, PT, SK, SI, ES
BG, CY, FI, EL, HU, IS, IT, LV,
MT, NO, PL, RO, SE, UK
LT
Complex Straightforward No information
-
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April 2016 I 40
Country Straightforward Complex
Netherlands 40 60
Norway 80 20
Poland 50 50
Portugal 45 55
Romania 75 25
Slovakia 40 60
Slovenia 50 50
Spain 40 60
Sweden 80 20
United Kingdom 60 40
According to helpdesks, a straightforward enquiry requires, on average, 2 days of work
and a complex enquiry about a week and a half.
Figure 17: How long, on average, does it take to respond to the following types of questions? (Question 49)
11 countries indicated they outsourced a number of enquiries (Belgium, Croatia,
Denmark, Estonia, France, Italy, Latvia, Liechtenstein, Lithuania, the Netherlands, and
Norway). They tend to outsource enquiries related to CLP, IUCLID5 and REACH-IT. Other
types of enquiries outsourced are related to workers’ exposure (Norway), physical-
chemical testing (France and Norway), and enquiries from foreign companies (the
Netherlands).
7
1
12
3
7
15
3
7
1
3 1
0 5 10 15 20 25 30
Complex questions
Straightforward questions
4 hours 1 day 3 days 1 week 2 weeks > 2 weeks No information
-
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April 2016 I 41
Figure 18: Types of enquiries outsourced by EU/EEA countries
3.6 Cooperation between helpdesks
20 helpdesks provided an opinion regarding the improvement of the cooperation between
helpdesks under HelpNet. 11 indicated that the current forms of cooperation were
appropriate, or had improved. The level of satisfaction is however higher for HelpNet
meetings than for HelpEx. 2 helpdesks have suggested that HelpEx was not user friendly,
mixing too much information (REACH, CLP and Biocides). 3 helpdesks have however
underlined the effectiveness of working groups under the HelpNet Steering Group and 5
have called for reinforcing them.