This will simplify the assessment of applications and reduce the cost and time required compared with the reporting route of obtaining national authorizations in multiple member states.

Based on practical experience, the reasons for selecting union authorization are as follows:

1. Harmonised assessment across EU countries

While national authorisations are managed by Member States independently, Union authorisations will be managed by ECHA, with the final decision coming from the EU countries and the European Commission. The Union authorization will initially simplify the process by ensuring coordination along member states, and eliminate the workload of having to repeatedly explain the authorized products to multiple countries. What is more, the intervention of ECHA not only promotes communication and coordination, but also urges the completion of the deadline of each stage, which undoubtedly plays a crucial role in the normal launching of the applicant’s products. Union authorisation ensures that the product information received by customers within the EU is consistent and clear.

2. More economical for multinational markets

Whether or not to choose Union authorisation depends on the actual situation of the company. If a company needs or is prepared to launch products in 10 or more EU countries, applying for Union authorisation for a product can greatly reduce the economic cost of obtaining individual national authorisations.

3. Close cooperation with authorities

The applicant should select the appropriate member state to act as evaluating authority, fully communicating the requirements of the authority to prepare the corresponding dossier. The working groups of the Biocidal Products Committee (BPC) will draw conclusions on the adequacy of the application and experts from each member state will facilitate the harmonization of assessments. The final decision will be taken by the European Commission and Member States. During this period, support from ECHA is available through each step. Some companies expressed they were given full guidance from ECHA when they applied for Union authorisation.

4. Innovating with a product family

The introduction of Union authorisation for a family of products can help a company innovate and launch new products more easily. For example, a product family consisting of several similar products can be authorized to obtain a Union authorization of all products through the authorization of a single product family. The enterprise can then set different formulations for different markets or develop new formulations for specific markets. The company can create different formulations for different markets, or launch a new formulation for one market.

Of course, the biggest challenges of union authorisation are timelines and fees. Generally speaking, the preparation of declaration can take 2-3 years and the official assessment cycle about 3 years. In terms of fees, the administrative fee for union authorisation to ECHA is over 40,000 euros. Applicants are also required to pay assessment fees to the evaluating country in accordance with the fee standards of each member state. Data charges are also a big expense. Therefore, the authorization before declaration should be based on the product market and company planning, to assess the economic costs. Secondly, if the company applies for a Union authorization, the declaration plan should be well planned. Third, keep close communication with the evaluating authority, and seek the support of experts on issues such as risk assessment and efficacy. Finally, if a Union authorization is finally obtained, the products will be put in any EU country by means of a simple notification.

REACH24H CONCULTING GROUP CHINA is regularly following up on the regulations of European biocides and will continue releasing the most updated information. We recommend that in order to ensure an orderly and responsible product authorization, companies with business within the EU market stay up to date on the latest developments.

Want to reach out to our team?

REACH24H Agrochemicals Division:

+86-571-87007037

maohongliang@reach24h.cn

Email: customer@reach24h.com