Forsigtighedstilgang – gevinst eller stopklods Precautionary Principle good or bad for innovation Bjorn Gaarn Hansen Head of Unit: Chemicals Directorate: Green Economy European Commission, DG Environment Copenhagen,

Contents 1. Caution, Precaution and the Principle 2. Risk in Chemicals Legislation 3. Precaution in Chemicals Legislation 4. Innovation in Chemicals Legislation 5. Conclusions

1. Precautionary Principle "The precautionary principle, which is essentially used by decision- makers in the management of risk, should not be confused with the element of caution that scientists apply in their assessment of scientific data." Commission Communication (2000) 1 – final of Caution is used when interpreting information -- Precaution is used when developing models to predict impacts -- The Precautionary Principle is implemented when the uncertainties are higher than normal

1. Precautionary Principle -Under Regulation (EC) 793/93 the precautionary principle was invoked 4 times: -- PentaBDPE:Led to restrictions -- OctaBDPE:Led to restrictions -- DecaBDPE:Led to testing (debromination) -- Bisphenol-A:Led to testing (3 gen study)

1. Precautionary Principle -And applied using Regulation (EC) 793/93, the GPSD and the EUs Scientific Committees: -- Phthalates: Led to restriction -No examples since 2007, when REACH entered into force.

1. Precautionary Principle "Assigning responsibility for producing scientific evidence is already a common consequence [of implementing the Precautionary Principle]. Countries that impose a prior approval (marketing authorisation) requirement on products that they deem dangerous a priori reverse the burden of proving injury, by treating them as dangerous unless and until businesses do the scientific work necessary to demonstrate that they are safe." Commission Communication (2000) 1 – final of Authorisation (eg Biocides, PPP, REACH)

2. Risk in Chemicals Legislation "EU Chemicals regulation is risk based" BGH Globally harmonised system for classification and labeling: --> Hazard Statements invoke Precautionary Statement, based on "if you know the hazard you can better control the risks".

2. Risk in Chemicals Legislation "Chemicals regulation is risk based" BGH Phase out of PBTs: --> PBTs accumulate in eg marine sediments and higher food chain species, which are places where it is virtually impossible to clean up, AND will eventually cause toxic effects. Exposures should therefore be minimised.

2. Risk in Chemicals Legislation "Chemicals regulation is risk based" BGH Restrictions to Consumers of CMRs: -->REACH and its predecessor legislation ban CMRs for consumer use above a certain concentration limit, as it is very likely that some of the consumers in the EU will end up being exposed to a too high dose.

3. Precaution in Chemicals Regulation "Chemicals regulation implements a cautious approach and precaution" BGH Examples are: - "Reasonable worst case approach" in risk assessment is based on precaution - Reversal of Burden of Proof in REACH

4. Innovation in Chemicals Regulation "Innovate: Make changes in something established, especially by introducing new methods, ideas, or products." OXFORD DICTIONARY EEAs "Late Lessons, Early Warnings" give many examples of how legislation, through bans of specific chemicals, has stimulated innovation and accelerated the development of safer alternatives.

4. Innovation in Chemicals Regulation " Substitution of hazardous by less hazardous substances " Basic Principle in OSH But also the act of substituting something hazardous by something less hazardous is innovation. This can be at - chemical design and development - chemical use, upstream and downstream

4. Innovation in Chemicals Regulation Substituting something hazardous by something less hazardous reduces costs, as less risk management is needed to ensure safe handling and use, increases safety, as the risk potential is reduced. Pre-requisites for an efficient substitution is: - fair chemicals market regarding hazard/risk information - equal playing field between economic operators Which is what REACH does……..

4. Innovation in Chemicals Regulation What differences between Precautionary Principle cases and the general substitution, through industry own activities or through restrictions, affect innovation? - time from regulatory attention to regulatory action? - predictability? - availability of alternatives?

4. Innovation in Chemicals Regulation The application of the Precautionary Principle is part of the bigger drive for substitution, which overall stimulates innovation. What is needed is: - Generally much better knowledge on chemicals - Increase predictability of regulatory action - Draw the lessons from the observation that chemicals seldom get less hazardous with time.

4. Innovation in Chemicals Regulation 7 th Environment Action Programme sets a longer term plan for creating a better chemical knowledge base We should all work to make REACH more predictable, whilst meeting its aims -REACH was intended to be faster, easier and more efficient than past legislation.

Conclusions Current legislation is based on risk, builds in caution and precaution and stimulates innovation through its general pressure to control risks and substitute. Within this 'big picture' the Precautionary Principle plays a less prominent role – but does contribute to stimulating innovation.

Thank you for your attention Bjorn Hansen, Head of Unit, Chemicals, DG Environment, European Commission, Brussels