Day 1 - Chemical Industry Regulation ConferenceWednesday, 25 September 2024

• Challenges and Learnings
• Lessons we have learnt – what worked well for us and what we found challenging?
• Timeline involved – from start to finish
• Advice to others

This is an online presentation

• Compiling comprehensive documents and simultaneous submission to multiple countries
• Fostering global harmonization by aligning regulatory requirements
• Sharing data on a global platform to promote consistency and its impact on reducing trade barriers
• Uniformity in crop protection measures enhanced international trade opportunities for farmers across the world

• Essence of Art 34
• Interests of original and generic companies
• Conditions for not submitting the data
• Comparability of PPPs
• Why there is no guidance?
• Conclusion of PAI (EU COM Post Approval Issues Expert Group) about procedure with Art34
• Interpretations of ’Art 34 submission’
• Clone registrations & sister registrations
• Mutual recognition of Art 34 ?
• Usage of the newest evaluation GDs?
• How will 30 month data protection evolve to 7 years?
• Different policy and practice of EU member states

This is an online presentation

• Scientific validity and reliability of these testing methods
• Criteria used by regulatory authorities to classify pesticides based on their neurotoxic potential
• Setting maximum residue limits (MRLs) in food products
• Research updates

• Assessing the safety, efficacy, and environmental impact of fertiliser products in different member states
• Facilitating trade and promoting a level playing field for manufacturers across the EU
• Accelerating the time to market for new products and promoting innovation
• Safety and quality of fertiliser products

• General information regarding the (EU) No 2019/1009 Regulation, especially the Module system and the categorization of the products
• Guidance on the compilation of the Technical Documentation, with particular emphasis on compliance of labelling requirements
• Specific requirements of biostimulant products, regarding the claims.

• The new regulation on the approval of safeners and synergists in PPPs and the review programme of the European Commission. Task Force formation
• Legal challenges on data protection and confidentiality in PPPs: key common issues and criteria applied by authorities; the case of art 34
• Borderline biostimulants /PPP and commercial disputes: the "dual use" concept, the importance of the product claim, relevant precedents and criteria applied by the authorities

This will be an online presentation

• Introduction of regulations on coformulants (2021/383 and 2023/547) and the progress on notifications by Member States
• Challenges for companies to maintain transparency as member states seek detailed data information
• Exploring the linkages between co-formulations and REACH

• Significance of co-formulants extends beyond product performance. They are also crucial in regulatory compliance and the smooth functioning of global supply chains
• Regulatory requirements for co-formulants increase, however are not always harmonized
• In a globally interconnected industry, these regulatory discrepancies can severely impact supply chains with potential production halts, increased costs or even delays in market entry
• An industry perspective on navigating through these challenges while keeping focus on safe innovation

• Scientific validity and reliability of these testing methods
• Criteria used by regulatory authorities to classify pesticides based on their neurotoxic potential
• Setting maximum residue limits (MRLs) in food products
• Research updates