1. Precautionary Principle– Use in EU Chemicals Legislation Bjorn Hansen Head of Unit: Chemicals European Commission, DG Environment Precaution and Innovation, 22-06-2015

2. Outline 1. Caution and Precaution in EU Legislation 2. Precautionary Principle in EU Legislation 3. 7 th EAP and Innovation 4. Predictability 5. Conclusions

3. 1. Caution and Precaution in EU Chemicals Legislation Caution: The scientific assessment of a chemical should entail a sensible dose of (critical) caution when analysing the data.

4. 1. Caution and Precaution in EU Chemicals Legislation Precaution: A precautionary approach is applied in much of the EUs chemicals legislation Example: Generic risk approaches - Chemicals and mixtures are labelled based on hazards and generic risk considerations to make users better aware (blindfolded at 1cm or 1km)

5. 1. Caution and Precaution in EU Chemicals Legislation Precaution: - CMRs cat 1 are banned for consumer use, as such or in mixtures up to a low concentration limit (500.000.000 consumers in EU, consumer products often not essential, CMRs consequences large). - Cut-offs in legislation. Biocides, PPPs, REACH

6. 1. Caution and Precaution in EU Chemicals Legislation Precaution: - conservative assessment factors are applied to extrapolate from limited database to humans and the environment

7. 2. Precautionary Principle in EU Chemicals Legislation Precautionary Principle: - In the Treaties (one of three environment principles, alongside polluter pays and pollution at source) - Authorisation Systems are systematic applications of the precautionary principle (e.g. Biocides, PPP and REACH)

8. 2. Precautionary Principle in EU Chemicals Legislation Precautionary Principle: - Cases from Regulation 793/93 (now repealed): 1. PentaBDPE(resulted in ban) 2. OctaBDPE(resulted in ban) 3. DecaBDPE(resulted in test) 4. Bisphenol-A(resulted in test) 5. Some phthalates(resulted in restriction)

9. 2. Precautionary Principle in EU Chemicals Legislation Precautionary Principle: - Under REACH is can be applied 1. identify uncertainties in risk assessment 2. assess consequences in risk management in risk management parts 3. assess socio-economic consequences of scenarios

10. 2. Precautionary Principle in EU Chemicals Industry Precautionary Principle: - Chemicals industry uses the precautionary principle very often in making their routine business decisions

11. 3. The EU's 7 th EAP - Chemicals The EU needs to deliver on: - cyclical economy - resource efficiency - non-toxic product cycles which put additional (or confirms existing) demands on our Chemicals Policy

12. 3. The EU's 7 th EAP - Chemicals The 7th EAP sets out to meet these challenges through the development of: EU strategy for a non-toxic environment, supported by chemical knowledgebases based on fact that predictability and knowledge support innovation

13. Keep Innovating (in Transparent Chemicals World): - Move from having information to accumulating knowledge (the ability to use information) - Chemical Companies become Chemical Knowledge Companies - Access and storage of information becomes a public good Need EU Chemicals (Exposure and Toxicity) Knowledgebase! 3. The EU's 7 th EAP - Chemicals

14. 2018: Develop an EU Strategy for a non-toxic environment, that is conducive to innovation and the development of sustainable substitutes including non-chemical solutions (building on the 2015 work)

15. Predictability has several facets: -- Regulation -- Industry Performance -- Scientific Opinion(s) -- Public Opinion 4. Predictability

16. 5. Conclusions - Precautionary Principle is well integrated in EU Chemicals Legislation - Experience in application exists - Better chemicals management needs better knowledge, more predictability, and the precautionary principle

17. Thank you for your attention Bjorn Hansen, Head of Unit, Chemicals, DG Environment, European Commission, Brussels http://ec.europa.eu/environment/chemicals