Health
Healthand
andSafety
Safety
Executive
Executive
Improving the efficiency
of the regulatory process
Rob Mason
Head of Regulatory Policy
Chemicals 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
Ensure a high level of protection for both human
and animal health and the environment
Safeguard the competiveness of European
agriculture
Issues
Hazard criteria
Zonal authorisations
Biodiversity and
ecosystems
Candidates for substitution
Comparative assessment
Cumulative and
synergistic effects
2014 review
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
biological substances
scoping protection goals
data protection
targeted and prioritised data requirements
zonal approach
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 – 100M
Savings:
- Not quantified