This report concerns the ‘Study to support the integration of REACH aspects into customs legislation/procedures’. This study focuses on the enforcement of REACH in import procedures and the release for free circulation procedure in particular. It aims to improve current processes and procedures for better REACH enforcement, with particular attention to short and mid-term solutions because of future implementation. It identified seven issues related to the free circulation procedure as having a relevant impact on REACH's enforcement. For these seven issues, the study proposes several solutions, focusing on those practically implementable in the short-to-medium term. The proposed solutions were based on research and questionnaires/interviews conducted with EU countries, customs authorities, national enforcement authorities and the European Chemicals Agency.
Study to support the integration of REACH aspects into customs legislation and procedures
The study on the impacts of REACH authorisation aims to assess the performance of the REACH authorisation system. The study provides evidence to assess whether authorisation is working as intended and is achieving its objectives of progressive substitution of SVHCs by less hazardous alternatives and risk control. The study includes also findings about the role of authorisation on the decisions to substitute substances of very high concern (SVHCs), reduce emissions to the environment and lower exposure of workers to SVHCs, as well as some insights into the costs and benefits of authorisation. The study involved:
- a review of existing literature
- surveys with industry, NGOs, the European Commission, the European Chemicals Agency and competent authorities from EU countries
- in-depth follow-up interviews with industry
- case studies on specific chemicals or issues
The REACH Baseline study tracks the effectiveness of REACH in risk reduction and improvement of the quality of data available for the assessment of chemicals. It uses a methodology established in 2007 that calculates Risk and Quality indicators.
The methodology to derive the Risk score (risk posed by a substance) and the Quality score (quality of the data available to assess the risk associated with a substance) was established in 2007. Yet, first applied in 2009 to a set of 237 reference substances. These were considered a representative sample of the chemicals available in the EU market before REACH entered into force.
The assessment was repeated after 5 years for the substances registered by August 2011 to feed into the first REACH review. The REACH Baseline Study – 10 years update analyses changes in the Risk Scores and Quality Scores based on registrations until September 2015. These include registrations from the second registration phase (by May 2013) as well as updates from dossiers registered before.
The study provides a comparison between impacts of EU REACH and impacts of corresponding legislation in China, Japan, the United States, South Korea and Canada. The comparison of how the different legal requirements affect competitiveness was made for the chemicals industry as well as for 3 selected downstream sectors (the automotive, the rubber and plastics and the textile industry). The study draws on a comprehensive comparison of differences and similarities between the legislation of the aforementioned countries. In addition, findings of a survey among business associations, companies from the EU and companies from non-EU countries were used to evaluate the different costs and benefits.
Final report (2 MB)
The REACH review 2013 identified the definition of substance identity and the determination of sameness of substances as one of the challenging aspects to implement the OSOR principle - 'one substance = one registration'.
The European Commission contracted a study which aimed at identifying common issues faced by registrants of substances under REACH and good practices in identification of complex substances, especially substances of unknown or variable composition, complex reaction products or biological materials (UVCBs).
The study found that over 2 400 substances (nearly a quarter of substances registered by 2013) can be considered complex when it comes to their identity and sameness. The study confirmed that substance identity remains a complex task for REACH registrants and there is a need to develop sector-specific materials through a collaborative approach to overcome these difficulties. The study develops seven factsheets to present the findings for some sectors.
The European Commission and the European Chemicals Agency will continue to design strategies to clarify and improve the reporting of the identity of substances on the basis of the findings of this study.
For more information, see the full study report.
List of annexes
Downloading of report, list and annexes (zip-file)
The study 'Monitoring the Impact of REACH in Innovation, Competitiveness and SMEs' (6 MB) evaluates the impacts on competitiveness and innovation, the operation the single market and impacts on SMEs following the introduction of the REACH Regulation, focusing on the 2010–2013 period. It contains an overall assessment of REACH Regulation in terms of effectiveness, efficiency, coherence and sustainability, identifies strengths and weaknesses of REACH implementation and provides policy recommendations.
Certain CMR 1A and 1B substances in articles
'The potential impact on industrial competitiveness of restrictions on certain CMR 1A and 1B substances in articles - Scoping study for the application of art. 68(2) of REACH to CMR substances requiring priority action'
- Final report (5 MB)
- Background (109 kB)
- Paper on “Criteria and procedure for the implementation of Article 68(2) of REACH: restriction of CMRs 1A and 1B in consumer articles” (421 kB) (7.11.2014)
The 1,4 Dichlorobenzene study: 'Socio-Economic Evaluation arising from a Proposal for Risk Reduction Measures related to Restrictions on 1,4 Dichlorobenzene' by RPA, June 2010
- Final report (1 MB)
- Background (109 kB)
The PFOA study: 'Analysis of the risks arising from the industrial use of Perfuorooctanoic acid (PFOA) and Ammonium Perfluorooctanoate (APFO) and from their use in consumer articles. Evaluation of the risk reduction measures for potential restrictions on the manufacture, placing on the market and use of PFOA and APFO' by RPS, January 2010
- Final report (3 MB)
- Background (109 kB)
The Borates study: 'Assessment of the risk to Consumers from Borates and the impact of potential restrictions on their marketing and use' by RPA, November 2008
- Final report (462 kB)
- Annex on Consultees (13 kB)
- Annex on use in glass (52 kB)
- Annex on use in other applications (77 kB)
- Background (109 kB)
Commission Staff Working Document - Impact Assessment Report - accompanying the Proposal for a Commission Decision relating to restrictions on the marketing and use of certain dangerous substances and preparations (Acrylamide), April 2011
Commission Staff Working Document - Impact Assessment Report - accompanying the Proposal for a Commission Decision relating to restrictions on the marketing and use of lamp oils and grill lighter fluids, May 2009
Commission Staff Working Document - Impact Assessment Report -accompanying the Proposal for a Commission Decision relating to restrictions on the marketing and use of certain Organostannic compounds, May 2009
Commission Staff Working Document - Impact Assessment Report accompanying the Proposal for a Decision of the European Parliament and the Council amending Directive 76/769/EEC relating to restriction on marketing and use of dichloromethane in paint strippers, February 2008
Impact Assessment Report accompanying the proposal for a decision on marketing and use restrictions on DEGME, DEGBE, MDI, Cyclohexane and ammonium nitrate (amendment of Council Directive 76/769/EEC), October 2007
Impact Assessment - accompanying the Commission Regulation amending REACH as regards Annex XVII (Cadmium), May 2011
Study on the Socio-economic Impact of a potential update of the Restrictions on the Marketing and Use of Cadmium final report by RPA (Risk & Policy Analysts Limited) December 2009 (revised in April 2010)
Impact Assessment of Potential Restrictions on the Marketing and Use of Dichloromethane in Paint Strippers final report and annexes (859 kB) by RPA, April 2007
Advantages and drawbacks of possible market restrictions in the EU final report (475 kB) by TNO-STB, November 1999
Risk assessment on targeted consumer applications, final report (647 kB) by RPA, September 2005
Impact Assessment of Potential Restrictions on the Marketing and Use of Certain Organotin Compounds, final report by RPA, October 2007
Advantages and drawbacks of possible market restrictions in the EU, final report (2 MB) by COWI, November 2004
Effectiveness of vapour retardants in reducing risks to human health from paint strippers containing dichloromethane final report (634 kB) by ETVAREAD (Expert Team for Vapour Retarding Additives), 1 April 2004
Risk of sensitisation of humans to nickel by piercing post assemblies final report (414 kB) by LGC Limited, 31 March 2003
Risks to health and the environment related to the use of mercury products final report (646 kB) by RPA (Risk & Policy Analysts Limited), 9 August 2002
The advantages and drawbacks of introducing Community-wide restrictions on the marketing and use of 2-(2-butoxyethoxy)ethanol (DEGBE), ETD/00/503314 final report & errata (6 kB) by RPA (Risk & Policy Analysts Limited), October 2001
Risks to health and the environment related to the use of lead in products final report by TNO, September 2001
Migration of phthalate plasticizers from soft PVC toys and childcare articles, ETD/00/503303 final report (299 kB) & appendix (942 kB) by TNO, 21 August 2001
Nonylphenol Risk Reduction Strategy final report by RPA (Risk & Policy Analysts Limited), September 2000
The availability of substitutes for soft PVC containing phthalates in certain toys and childcare articles, ETD/99/502498 final report (15 kB) by RPA (Risk & Policy Analysts Limited), July 2000
PVC: Life Cycle Assessment (LCA) of PVC (2 MB) and of principal competing materials by PE Europe GmbH, July 2004
PVC: Chemical recycling of plastics waste (700 kB) (PVC and other resins) by TNO Institute of Strategy, Technology and Policy, December 1999
The European Commission, in co-operation with the European Chemicals Agency (ECHA), has carried out an Analysis and Design Study to provide industry with IT-tools to generate Exposure Scenarios (ES), Chemical Safety Assessments (CSA), and Chemical Safety Reports (CSR).
Results of the study:
- Use Case Model
- Use Case Specification
- Analysis Model
- Software Architecture
- Stakeholder Request Analysis
The planned tools will be further developed by the European Chemicals Agency (ECHA).