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EU to adjust intro of new data requirements for agchem products

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  • [ Industry Dynamics, 2014-8-6, Agrow, 1303 Hits ]

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    Deadlines for the imposition of new agrochemical data requirements on product applications are to be removed under proposals from the European Commission. The planned change would be made to EU Regulation 283/2013, which updated data requirements to reflect the stricter approval conditions introduced with the EU agrochemical registration Regulation (1107/2009 – Agrow No 662, p 10). At the time, transitional measures allowed companies to continue to use the former data requirements if they submitted their product approvals by December 31st 2015. The Commission proposes to remove this date from the transitional measures in Regulation 283/2013.

    Instead, product applications could continue to use the former data requirements provided that the relevant active ingredients had not already had their approvals renewed under the third ai renewal programme, named AIR-3. With regard to ai applications, the imposition date of the new data requirements has already passed and would remain unchanged. Companies were only able to use the former data requirements for ai applications submitted by December 31st 2013.

    The relaxation of the transitional arrangements for data requirements for product applications is to avoid disparities in the assessment of data for ais and for the products that contain them, the Commission notes. It would allow, “in certain cases”, the submission of ai data in product applications that is in accordance with the data requirements that were in force at the time that the ai was approved or renewed. The Commission also notes the need to preserve harmonised assessments throughout the EU, and avoid member states in different geographic zones adopting different data requirements when assessing the same products.

    Earlier this year, industry representatives raised the problem of complexity and confusion in potential cases where old data requirements applied to an ai, but the subsequent product submission could be subject to the new requirements (Agrow No 687, pp 11-13). The situation has become more acute by the ongoing delays in completing EU procedures for renewing ai approvals. Numerous ais have had their existing authorisations extended because of slow progress in dealing with applications for renewal (Agrow passim).

    The Commission forwarded the proposals to EU Ministers in July. The proposals received a positive vote from the EU Standing Committee on the Food Chain and Animal Health earlier this year.

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