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SMEs, all pros and cons of biocide regulation

The compliance with the provisions of the Biocide Regulation has proved to be hard and expensive even for big multinationals. How can small and medium-sized companies effectively compete in this market?

Actually, the Regulation favours SMEs very much, for instance with reduced fees, when the appropriate procedure has been followed to demonstrate the SME status. Besides, SMEs can also associate in consortiums in order to reduce the costs required for the registration of a biocidal product (along with the costs of the fees due to the authorities, the expenses for the preparation of the dossier should also be considered. The latter is made of several studies, and in order to be prepared in compliance with the norms, the competence of experts in various scientific subjects is required). They can also take advantage of the possibility to submit a letter of access to dossiers already submitted instead of embarking in the preparation of a new one.

What is a SME?

One of the issues to be solved is the definition of SME. The officially acknowledged – though not binding – definition is the one proposed in the Commission Recommendation 2003/361/EC of 6 May 2003, classifying enterprises based on their turnover and staff numbers. Based on this recommendation, medium-sized enterprises are those with fewer than 250 employees and an annual turnover not exceeding EUR 50 million; small enterprises are those with fewer than 50 employees and annual turnover not exceeding EUR 10 million, that become microenterprises when they employs fewer than 10 persons for an annual turnover under EUR 2 million. Unfortunately, however, the situation is complicated by the so called “linked enterprises”, with a series of defined relations indicating the control by other enterprises with a consequential increase in the acknowledged turnover.

It should also be considered that the SME status should be preliminary obtained before submitting the authorisation application for a biocidal product, by submitting an online request via the register, where the outcome of the Agency’s assessment will also be made available.

The fees

As for the fees, the Regulation expressly acknowledges the special needs of small- and medium-sized enterprises and ensures reductions of the due fees ranging from 20% to 60%. The fees concerned by these reductions are those regarding active substances, approvals, renewals of approvals, inclusion in Annex I. On the other hand, 10-30% reductions are granted to future holders of Union authorisation for a biocidal product or for its renewal. Considering that the fees are quite high, granting reductions plays a relevant role in the possibility for SMEs to continue to operate on the market.

Member States, however, appear to be reluctant to follow the Commission recommendations. Almost all MSs have opted for a single fee, that can be integrated by further fees, and measures supporting SMEs are very limited. Some countries – including Italy and Romania – have provided for measures to support competitiveness of small- and medium-sized enterprises operating in the sector of biocides.

Data sharing

The compliance with regulating provisions is even more expensive than fees, especially the need to own or have access to data demonstrating that active substances and products are suitable for marketing. The partial review of the Biocide Regulation was actually grounded in the need to ensure the possibility of limiting unrequired tests (and therefore additional costs) to the minimum, especially for small- and medium-sized enterprises, promoting free competition between all operators.

However, as far as data sharing is concerned, SMEs find themselves to have to comply with the same obligations of anyone owning or accessing data, and it is hard to identify a context that could be more favourable for them without creating any discrimination.

The set-up of SME groups to negotiate costs and share resources and experiences can be a first step to go back and fight on equal terms: there is no regulation forbidding data access by a group rather than by a single company. A solid, considerable group could also ask for deferred payments to be granted to all SMEs. This seems so far the best solution to counterbalance the positions currently held by big-sized companies in the market.

Written by Federica Montozzi

Foto di MildredR da Pixabay