Health and Safety Executive Health and Safety Executive Improving the efficiency of the regulatory process Rob Mason Head of Regulatory Policy Chemicals.

Health and Safety Executive

Health and Safety Executive

Improving the efficiency

of the regulatory process

Rob MasonHead of Regulatory PolicyChemicals Regulation Directorate

Agri-tech strategy

A clear and consistent regulatory framework is important in providing companies with a stable environment and plays an important role in securing consumer confidence. As it can typically take a decade or more to bring new innovations from the laboratory to the market, it is important that companies have confidence to make long-term investments. It should be a given that regulation responds to changing market conditions, is not overly burdensome and does not stifle innovation.

Prime Minister’s Business Task Force

Problem EU regulation denies business access to innovative crop protection products. This hinders EU businesses in their efforts to improve crop yields and quality. As a result, EU farming businesses are disadvantaged on world markets.

Prime Minister’s Business Task Force

Analysis Farming businesses have said that EU rules mean they are denied access to new and innovative crop protection products. Existing products can also be removed from the market when they are reviewed, even though they are often still used in non-EU countries. All of this reduces the competitiveness of EU farmers. The reason is that EU decision-making is not based solely on risk. This leads to decisions for approval that are based on theoretical concerns rather than sound scientific evidence. The assessment process is complex, with businesses often feeling that the decision made does not fit the evidence. This also discourages agri-chemicals companies from investing in the EU, undermining the competitiveness of the European industry.

Prime Minister’s Business Task Force

Recommendation The European Commission should propose amendments to the Plant Protection Products Regulation to introduce a process for evaluation that is based on scientific risk assessment alone. The European Commission’s guidance also needs updating, so that it does not impose excessive cost in exchange for negligible health or environmental benefits.

Issues

Regulation 1107/2009

Ensure a high level of protection for both human and animal health and the environment

Safeguard the competiveness of European agriculture

Issues

Regulation 1107/2009Hazard criteria

Zonal authorisations

Candidates for substitution

Comparative assessment

Cumulative and synergistic effects

Biodiversity and ecosystems

2014 review

Regulation 1107/2009

Article 82 Review clause By 14 December 2014, the Commission shall present a report to the European Parliament and the Council on the functioning of mutual recognition of authorisations and in particular on the application by the Member States of the provisions referred to in Article 36(3) and Article 50(2), the division of the Community into three zones and on the application of the criteria for the approval of active substances, safeners and synergists as set out in Annex II and the impact thereof on the diversification and competitiveness of agriculture as well as on human health and on the environment. The report may be accompanied, if necessary, by the appropriate

legislative proposals to amend those provisions.

Methodology

Identify opportunities – text analysis and stakeholders

Comparison other legislation

Feasibility and cost benefit

Conclusions and recommendations

Conclusions

risk based approach

scoping protection goals

targeted and prioritised data requirements

zonal approach

data protection

biological substances

risk based approach

- simplification?- high cost – low benefit- other legislation- periodic revisions- remove comparative assessment

Savings:- Hazard criteria €415 - 820M- Periodic revisions €130 - 135M- Comparative assessment €10 – 100M

scoping protection goals

- focus resources- increase efficiency- monitoring needs

Savings:- Up to €38 B

targeted and prioritised data requirements

- necessity of each test- exposure based- scale of use- assessment factors

Savings:- €222 - 230M

zonal approach

- obligatory- one stop

shop

Savings:- €32 – 34M

biological substances

- separate requirements and guidance

Savings:- €22 – 23.5M

data protection

- reduce MS involvement

Cost:- €10 – 100MSavings:- Not quantified