Civil Law Product Liability under REACH and CLP Some Basics

Transcription

1 Civil Law Product Liability under REACH and CLP Some Basics Regulatory Services Zone Chemspec Europe, Budapest, 18 to 19 June 2014 Hans-Jochen Lueckefett MR a.d. Lawyer 2 AGENDA 1. New aspects of product liability 2. Product liability in the value chain 3. Some legal basics 4. Product defects some examples 5. Product liability REACH, CLP and RoHS 6. The customer s legal position 7. Conclusions 1

2 3 WHY THIS PRESENTATION? The deadlines of pre- registration, registration 2010 and registration 2013 are about to disappear behind the horizon. The registration deadline 2018 is still behind the horizon too. Is there time to relax in the interim, monitoring the evolution of the candidate list and Annex XIV? Unfortunately there is no break. It was not in the focus of legislators, but REACH, CLP and other substance and product related legislation do have a strong impact on civil law. 4 NEW ASPECTS OF PRODUCT LIABILITY(BEYOND FUNCTIONS) Substances and Mixtures Energy Efficiency Supply of Information Safety 2

3 5 PRODUCT LIABILITY THROUGHOUT THE VALUE CHAIN Product Design Manufacturing Instructions Monitoring 6 SOME LEGAL BASICS There are 3 sources of product liability: 1. Specific product liability legislation e.g. for Germany: ProdukthaftungsG based on Council Directive 85/374/EEC of 25 July 1985 concerning liability for defective products amended by EU Directive 1999/34/EC of 10 May Civil tort laws e.g. for Germany: 823 ffbgb and France: Art ffcode Civil 3. Contractual obligations 3

4 7 SOME LEGAL BASICS(2) Essential element of product liability is the defect ; there are 3/4 basic types of them: 1. Constructive defects 2. Defects in the manufacturing process 3. Missing or wrong product instructions 4. Monitoring of products put on the market 8 PRODUCT DEFECTS SOME EXAMPLES 1. Defects of construction Such defects have an impact for all units of the same type of product. Famous example is the car airbag; German Federal Court of Justice (VI ZR 107/08) 2. Defects in the manufacturing process There are caused by material deviations in manufacturing. Not the whole series of a product but a single production cycle may be affected. 3. Missing or wrong instructions Instructions must be clear and intelligible basically to all customers. Frequent example: translation of instructions not taking into account the legalities of the country of destination; e.g. USA EU. 4. Monitoring of the product: are there any risks arising from usage surfacing after product introduction? 4

5 9 PRODUCT LIABILITY REACH, CLP AND ROHS 1. Defects in Construction Examples are a wrong risk assessment or a non-compliant composition of the product. The authorization of a product may indicate that there is no defect. However, technological development may lead to a different evaluation later on. A neglected substance restriction (Art. 67 ff REACH) may be classified as defect. The same is true for wrong and insufficient packaging. 2. Defects from manufacturing Banned or hazardous substances beyond legal thresholds. Good examples of RoHS: Lead and tetravalent-> hexavalent chromium. 10 PRODUCT LIABILITY REACH, CLP AND ROHS (2) 3. Wrong or missing instructions Wrong or misleading translation of instructions into other languages. Missing instructions in case of risks which cannot be eliminated by product design (see the airbag case of the German Federal Court of Justice (VI ZR 107/08)). The CLP classification of a product is an important source of information. Local legal instruction requirements must be taken into account (e.g. Chemical legislation in Denmark). 5

6 11 CONCLUSIONS 1. The first wave of activities after REACH been put into effect ( ) is not the end of the story. Compliance with REACH, CLP and RoHS are important elements of product liability 2. Product liability requires attention throughout the whole life cycle and along the entire value chain. 3. Today customers have access to much more information, feeding legal actions. 4. REACH-Compliance is an important element of product liability. On the one hand side the necessary efforts for regulatory compliance grew dramatically. Noncompliance may indicate defects. 5. On the other hand REACH compliance may be a barrier to legal actions based on product liability. However compliance is an indication for the absence of defects only. 6. Documentation is key. 12 FINAL REMARK The presentation covered some basics. There is a lot more to be taken into consideration such as How about limited access to studies in case of a joint registration and the limitation of liability as part of a LoA? The personal responsibility of company executives, US class actions and the risks of the US discovery based on an international network of lawfirms. You may want to wait for my next presentation if admitted by ChemSpec OR 6

7 13 CONTACT US! For questions please do not hesitate to contact us! 1cc GmbH GEO PARK I, Max-Eyth-Strasse Holzgerlingen, Germany T F compliance@1cc-consulting.com 7