Clifford Chance

Challenges of mandatory data sharing under EU legislation on biocidal products

11 September 2017

Biocidal products are used in nearly every industry, including the chemicals, heatlhcare, food, cosmetics, textile, toys, automotive and construction sector. The coming into force of Regulation (EC) No 528/2012 concerning the making available on the market and use of biocidal products (so-called "Biocidal Products Regulation", "BPR") in all EU Member States in 2013 caused great turmoil on the global biocides market. In the pursuit to curb animal testing, the BPR provides int. al. for mandatory sharing of data obtained by means of specific animal testing. The European Chemicals Agency ("ECHA") acts as an intermediary and connects prospective applicants with established data owners. While this helps new players to enter the market, it diminishes the economic value of data in the first place since there is no longer the appealing prospect of exclusive data exploitation.

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