SME fees under Biocidal Products Regulation
Small and medium-sized enterprises established in the European Union can benefit from reduced fees under Biocidal Products Regulation, depending on their size and provided that certain conditions are met. In order to do this, companies need to submit the documentary evidence proving their entitlement to such reduction in advance of the actual application. The conditions and the instructions on how to submit the documentation for the SME check are described in more detail below.
Before you request an SME check, make yourself familiar with the relevant EU definition. The Commission Recommendation 2003/361/EC is the sole authentic basis for determining the conditions regarding qualification as micro, small or medium-sized enterprise.
Before submission of an application to the Agency for approval, renewal or inclusion in Annex I to Regulation (EU) No 528/2012 of an active substance or for Union authorisation of a biocidal product or biocidal product family, submitted in accordance with Articles 7(1), 13(1), 28(4), 43(1) or 45(1) of that Regulation respectively, containing a claim for SME reduction, the prospective applicant shall submit to the Agency the relevant elements proving entitlement to such reduction by virtue of the status of SME in the meaning of Recommendation 2003/361/EC.
It should be noted that the companies can benefit from reduced fees only when the active substance is not a candidate for substitution and when the product does not contain an active substance which is a candidate for substitution.
Therefore, in case the application concerns such a substance or a product, the company cannot request an SME check either.
In the case of an application for approval, renewal or inclusion of an active substance in Annex I to Regulation (EU) No 528/2012, it is the size category of the active substance manufacturer established in the Union that determines the entitlement to reduced fees.
In case of an application for product authorisation or renewal of product authorisation, it is the size category of the prospective authorisation holder established in the Union that determines the entitlement to reduced fees.
Therefore, in case the entity submitting the application is e.g. a consultant, it is important to assess the company size of the client.
Step-by-step instructions on assessing the company size category.
- Documentary evidence* showing the ownership structure of the enterprise including all direct and indirect partner and linked enterprises, upstream and downstream, taking into consideration any shares, voting rights or other exercise of influence relevant to determining linkages/partnerships in the meaning of Article 3 of the Annex to the Commission Recommendation 2003/361/EC.
*As documentary evidence showing the shareholders of a company, some of the following might serve including the latest amendments with the allotment of shares: Articles of association, Incorporation documents, Memorandum of association, company's shareholders book, etc.
- Copies of the official audited financial accounts along with the accompanying notes and annual reports for the two latest approved fiscal accounting periods as well as those of any partner and/or linked enterprises in accordance with Articles 3, 4 and 6 of the Annex to the Commission Recommendation.
- Official certificate/information from an Official Authority** confirming the headcount of staff that corresponds to the number of annual work units (AWU), in accordance with Article 5 of the Annex to the Commission Recommendation, for each of the two latest approved accounting periods. If this information is included in the annual reports or the notes to the audited financial statements, you are not required to present these documents.
**An official certificate giving information on the company's headcount of staff may be obtained from, but not limited to, some of the following national/local institutions: tax office, revenue agency, insurance office, labour office, statistical office, health insurance institute, private health insurance company etc.
Make sure to send the documents specified in point 1, 2 and 3 above for all direct and indirect partner and linked enterprises, upstream and downstream, taking into consideration any shares, voting rights or other exercise of influence relevant to determining linkages/partnerships in the meaning of Article 3 of the Commission Recommendation.
Note: If the enterprise and/or any of its partner and linked enterprises are drawing up consolidated accounts or are included through consolidation in the accounts of another enterprise, please send the consolidated statements with the accompanying notes to them.
First of all, the companies need to make sure that they are familiar with the relevant SME definitions and that the necessary documentation listed in the "Documentary evidence needed section" is available, not only for the company concerned, but also for each of the partner and/or linked enterprise as well.
The application for an SME status can be submitted through R4BP 3 tool. In order to provide the documents, the active substance manufacturer or the prospective authorisation holder is required to sign-up in ECHA accounts and proceed to R4BP submission tool. Under the ‘NEW APPLICATION' tab, select submit application for ‘SM-APP – SME Verification' and the submission wizard will guide you through the submission process.
Please check your tasks and messages in R4BP 3 regularly. You may receive authority requests for more information through R4BP 3 with a deadline. The requests will appear under the ‘TASKS' tab in R4BP 3. If you fail to meet the deadline, your application may be rejected or the evaluation may be completed disregarding the information that has been provided too late, depending on the processing step. The decision on your application for recognition of SME status will be communicated through R4BP 3.
Please note that the size of an individual attachment cannot be above 10MB.Therefore, in case you have very large attachments or more than 6 attachments to be submitted, please create a zip archive where you include all files and upload the zip file as attachment.
Within 45 days of receipt of all the relevant elements, the Agency shall decide what SME status, if any, can be recognised.
A recognition of an enterprise as an SME shall be valid for applications submitted under Regulation (EU) No 528/2012 for two years.
An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against a decision taken by the Agency on the company's SME status.
Fee reductions for applications for the approval, renewal of approval, inclusion in Annex I of active substances if the active substance manufacturer is an SME established in the Union, except where the active substance is a candidate for substitution
|Type of enterprise||Reduction (% of the standard fee)|
|Micro enterprise|| |
Fee reductions for applications for the granting and renewal of Union authorisationof biocidal products or biocidal product families, if the prospective authorisation holder is an SME established in the Union, except where the product contains an active substance which is a candidate for substitution
Type of enterprise
|Reduction (% of the standard fee)|