Table of contents
- Active substance
- Determining whether a product is a biocide
- Choosing a procedure
- Article 95
- Sending a dossier and administrative management
- Fee payment
- Dossier processing times
- Annual contribution
- Communication with the "biocide" department
- Efficacy requirements: norms and tests
- CLP - New labelling
- The Addvisory Committee on Biocidal Products (CAB)
- Approvals
Biocidal products fight harmful organisms by means of a chemical or biological action, repelling them, rendering them harmless or destroying them. To do this, every biocide contains one or more active substances that act directly on the harmful organism targeted.
Please note: A closed list of active substances for biocides has been drawn up at the European level. Certain active substances are approved and others are currently being assessed or are pending in the European review programme.
Only biocides containing one or more active substances listed at European level can be placed on the European (and Belgian) market. Therefore, before submitting an authorisation or registration application for a biocidal product, you first need to check whether the active substance(s) is/are on the European list (see below).
It is important to check whether all the active substances in the biocidal product are approved or are part of the European review programme for active substances. This can be consulted on the European Commission website, particularly if the active substances are listed in Annex II of Regulation (EC) No 1451/2007 for the product types in question:
List of approved active substances: Biocides - list of approved substances (EU)
Review programme for active substances: Review programme (EU)
If this is the case, you must then check whether this active substance has been approved or is part of the review programme for the product types targeted by your biocidal product (the list of product types can be found opposite on the "Biocides" homepage or by following this link: 4 groups and 22 types of biocides in compliance with Regulation (EU) no. 528/2012.
If the active substance is not included in any of these lists, the biocidal product containing it cannot be registered or authorised for the Belgian or European market. You may, however, submit an application for the recognition of an active substance at the European level.
The procedure is specified on the website of the European Chemicals Agency (ECHA).
2. DETERMINING WHETHER A PRODUCT IS A BIOCIDE
To make sure that a product is actually a biocide, you should refer to the definition of a biocide according to the European Biocides Regulation 528/2012: see the homepage opposite "biocides" which includes the definition, the 4 groups and the 22 types of biocides.
Furthermore, it is not always easy to determine the status of a product. Certain products are halfway between a biocide and a medicine, or a veterinary medicine, plant protection product or cosmetic product, for example.
If in doubt, do not hesitate to contact us or to consult the European websites:
If the active substance(s) has/have been checked, you need to decide which procedure to follow:
European procedure
If the active substance(s) has/have been approved for all product types, you must follow one of the following European procedures:
- National authorisation
- Mutual recognition
- EU authorisation
- Simplified authorisation
National procedure
If the active substance(s) is/are included in the list of the review programme for the product types in question and has not yet been approved for these product types, you must follow one of the Belgian national procedures (see opposite pages):
- New registration application
- Modification of an existing application
- Application for a product identical to one already authorised in Belgium
- New product based on authorisation in another EU country
- Parallel trade (import)
- Tests or experiments
- Certificates of free sale
Concerning your current authorisation(s) or notification acceptance(s) or your registration(s) (identified hereinafter under the term "authorisation") in Belgium, compliance with article 95 is your main responsibility in your capacity as the authorisation holder. Check in good time for the products for which you are the authorisation holder whether the supplier for the active substance(s) present in the biocide - or, as the case may be, of the biocidal product itself - is/are specified on the list of article 95 and/or whether the supplier intends to register on the list of article 95. If this is not the case, you need to make a timely switch to a supplier who is specified on the list of article 95. This obligation also applies to products of which the active substance is generated in situ from one or more precursors; in other words the producer or the supplier of this/these precursor(s) must be included on the list of article 95.
Article 95 of the biocide regulation 528/2012 states that as of 1 September 2015, a biocidal product shall not be made available on the market if the manufacturer or importer of the active substance(s) contained in the product, or where relevant, the importer of the biocidal product, is not included in the list referred to in paragraph 2 (of article 95 of the Regulation) concerning biocides for the type of products applicable. The relevant substances are all active substances for which a European dossier has been submitted in compliance with the provisions of Directive 98/8/EC (Directive on biocidal products) or of the Regulation on biocidal products, and which has been accepted or validated.
The ECHA (European Chemical Agency) draws up the list referred to in article 95 and keeps it updated. The list includes active substances for which a European dossier has been submitted ("relevant substances") and which can only be sold as an active substance or in a biocidal product by suppliers established in the European Union who are included on the list for the product types indicated.
The list only includes suppliers (or their representatives in the European Union) who have, or have access to, a full EU substance dossier, or an equivalent dossier. The objective of this regulation is to combat opportunistic "free riding" and thereby encourage honest competitive relations. Thanks to this regulation, it will no longer be possible after 1 September 2015 to sell a biocidal product without having co-invested in the research on the active substances.
Persons who have submitted substance dossiers integrated within the examination programme must cooperate in the registering of suppliers of substances or products on the list referred to in article 95, by providing, for a reasonable fee, a letter of access to all of the toxicological, ecotoxicological, and "fate and behaviour" studies. The contact details of the persons who have submitted substance dossiers and who are included on the list can be requested from the ECHA. In the event of failure of negotiations between suppliers and applicants with regards to a letter of access, the EHCA will establish the fee amount. The list referred to in article 95 as well as additional information concerning the procedures to follow in order to register on this list are available on the ECHA website.
Two transitional measures are anticipated:
- For the biocidal products and active substances which are subject to the Regulation concerning biocidal products, but which do not fall within the scope of the Directive concerning biocidal products, for example "in situ" products without a biocidal purpose, a different regulation is applicable. It is set out in article 93 of the Regulation concerning biocidal products. The deadline for submitting an active substances dossier is 1 September 2016. The requirement to be included on the list referred to in article 95 shall therefore only apply from the moment that the submitted dossiers have been validated.
- For the substances which, in compliance with article 15 of Regulation 1062/2014, are integrated within the work programme for the systematic examination of all the existing active substances contained within biocidal products (e.g. substances which previously fell within the derogation for food and feed), the obligation of article 95 shall only apply when the dossiers have been submitted and validated, in compliance with the provisions of Regulation 1062/2014.
Certain active substances are exempted from this obligation: the suppliers or producers of active substances included in category 1 up to 5 or 7 of Annex I of the Regulation concerning biocidal products do not need to be included in the list referred to in article 95. These are substances which are recognised within the European Union as being low-risk substances.
5. SENDING A DOSSIER AND ADMINISTRATIVE MANAGEMENT
When your registration application dossier is ready, it can be sent as indicated in the corresponding procedure.
You must first pay the appropriate fee for the application /procedure for a biocidal product (see "fee payment" below).
Once the fee has been paid, the application will be subject to an administrative assessment (presence of the required documents and data).
If everything is in order (administratively admissible), a (limited or full) scientific assessment is carried out. The Advisory Committee on Biocidal Products (CAB) will issue its recommendation on the basis of this assessment. Following this recommendation, the above-mentioned application will be either approved or rejected.
In the case of a limited assessment, the dossier is processed and the registration is granted for the biocidal product covered by the application. The registration includes the conditions you have to fulfill in order to be allowed to place the biocidal product on the Belgian market.
In the case of a full assessment, the Advisory Committee on Biocidal Products (CAB) delivers its advice. Depending on this advice, your application is approved or refused. If your application is approved, the registration is granted. The registration includes the conditions you have to fulfill in order to be allowed to place the biocidal product on the Belgian market.
Once your product has been registered, you may request administrative or scientific changes. See also the table of fees for the cost of each application.
All the registered products are public and published on this website under the heading "list of authorised biocides". This list is updated weekly.
Appeals: If your application to place the biocidal product on the market is partially or entirely refused, you may launch an appeals procedure with the Belgian Supreme Health Council for all the national procedures set out in the Royal Decree of 4 April 2019.
You must pay a fee for the processing of your dossier, regardless of the type of application.
A table of fees will give you an idea of the amounts to be paid, depending on the type of application, as well as the ways in which you can make this payment.
For all applications the fee must be paid according to the invoice issued in the Gestautor application. This invoice indicates the amount to be paid, the account number and the structured reference to be stated when you settle your payment.
Dossier processing time varies depending on the procedure. Please see the national procedures sections opposite for more details.
For an administrative application: ± 45 business days
For a registration application (with limited assessment): 40 business days – 95 business days
For a registration application (with full assessment): 225 business days – 405 business days
When a biocide is registred, notified or authorised, it also receives a score which corresponds to hazard points calculated according to the hazard statements (H phrases) (Royal Decree of 13 November 2011 setting the fees and contributions payable to the Commodity Fund.
In accordance with the Royal Decree of 4 April 2019 (Art 39), authorisation, notification and registration holders must declare the quantities of biocides placed on the Belgian market to the FPS before 31 January each year. The FPS then calculates the amount of the annual contribution to be paid, on the basis of both the score and the quantity declared.
The amount of the annual contribution therefore depends on:
- the annual quantity of biocide placed on the Belgian market the previous year, and
- the number of points allocated to the product (this varies depending on the hazard categories attributed to the product and is mentioned in the registration).
The following procedure must be followed to declare the annual quantities placed on the Belgian market:
- During the first week of January, your contact person will receive an email referring to our automatic message in the Gestautor application.
- He/she will subsequently have to declare in the application the annual quantities of each authorised product placed on the market.
- Upon declaration of the annual quantities, he/she will receive an automatic message in the Gestautor application acknowledging receipt of the declaration. The calculation of the sum of the annual contribution and the issuing of the corresponding invoice happen simultaneously. Please do not make any payment until you have received this invoice in the application. This annual contribution must be paid before 31 March each year, under penalty of increase.
For any questions regarding the declarations of the annual quantities of biocides placed on the market and the amount of the annual contribution to be paid, please send an, email: volum.gestautor@health.fgov.be.
9. COMMUNICATION WITH THE “BIOCIDES” DEPARTMENT
The established workflow means that the person named in the electronic dossier (yourself, one of your colleagues or a consultant, for example) receives automatic notifications and/of tasks in the Gestautor application during the different application processing stages, to keep them informed of the progress of the dossier.
If you have any questions, please consult our FAQ or write to us at info.biocides@health.fgov.be.
10. "EFFICACY" REQUIREMENTS: NORMS AND TESTS
A large number of efficacy criteria affect the authorisation of a biocidal product and depend primarily on the type of product. Every claim must be proven by tests carried out according to statistically proven methods.
At the Belgian level, the efficacy requirements depend on the assessment procedure. In the case of a limited assessment, the efficacy is assessed if the product claims to be effective against a specific target organism (genus, species or alike) or according to specific norms. If applicable, a report on the tests performed according to standard methods have to be added to the electronic dossier. In the case of a full evaluation, every product claim must be proven by appropriate tests. Whether it be applications for a product registration at Belgian level or application for a product authorisation at European level, we follow as closely as possible the efficacy guidance published on the ECHA website.
For the efficacy part of every dossier, we refer to the various articles of European Regulation 528/2012 and more particularly Annex VI - §52, for the methods to be used to prove the efficacy of a product:
"Testing should be carried out according to Union guidelines where these are available and applicable. Where appropriate, other methods from the list below can be used. If relevant acceptable field data exist, these can be used: ISO, European Standardisation Committee (CEN) or other international standard method - national standard method - industry standard method (if accepted by the Member State) - individual producer standard method (if accepted by the Member State) - data from the actual development of the biocidal product (if accepted by the Member State)".
As a result, for the registrations in Belgium, we only accept tests carried out in accordance with the above-mentioned standards and guidelines. Finally, it should be stressed that data from scientific literature (published in recognised scientific journals) is only considered as supporting data and cannot replace efficacy data obtained from tests carried out according to the standards, guidelines and guides currently in force.
For the full document, download the PDF version: Evaluation of the efficacy of biocidal products.
The CLP is the new European Regulation 1272/2008 on the Classification, Labelling and Packaging of substances and mixtures. This Regulation came into force on 1 December 2010 for substances and has replaced existing legislation on substances and preparations (DSD and DPD). The transition period had been extended until 1 June 2017.
Since 1 June 2017, all chemicals on the European market have to be labeled pursuant to Regulation 1272/2008.
Applications for a CLP classification or a modification of CLP classification under the national procedure are to be sent to the competent department using the C4-form in the Gestautor application.
We remind you that you are responsible for adapting your labels and safety data sheets according to the latest valid registration, report and/or SPC (summary of the product characteristics) regarding the product.
12. THE ADVISORY COMMITTEE ON BIOCIDAL PRODUCTS
Mandate
The Committee assesses the European authorisation and, in the event of a full evaluation, Belgian registration applications. These assessments are based on efficacy reports, physical and chemical properties, potential toxicity for humans and the environment, exposure to humans and the environment, and behaviour in the environment. On the basis of these assessments, the Committee formulates an advisory opinion on the risks and efficacy of a biocidal product. It also decides whether a biocidal product belongs to the closed circuit.
Composition
- a President who is a technical expert of the DG Environment;
- a Vice President who is a technical expert of the FPS Employment, Labour and Social Dialogue
- five members who are technical experts of the DG Environment;
- a member who is a technical expert of the DG Environment’s inspection department;
- a member who belongs to the scientific staff of Sciensano
- three members representing the three Regions;
- a member who is a technical expert of the Federal Agency for the Safety of the Food Chain (FASFC);
- a member who is a technical expert of the Federal Agency for Medicines and Health Products (FAMHP);
- a member who belongs to the scientific staff of the Poison Centre;
- a member who is a technical expert of the DG Animals, Plants and Foodstuffs.
With the exception of the president, who is replaced by the vice-president, a substitute member belonging to the same institution is appointed for each member.
For placing biocides on the market:
- National authorisation (Authorisation n° XXXXB)
- National registration (Registration n° BE-REG-XXXXX)
- National notification (Authorisation n° NOTIFXXX)
- European authorisation (Authorisation n° BE20XX-XXXX)
- Parallel trade/import (Authorisation n° XX/IP)
Document
-
Rétributions biocides 2019 XLSX document - 25.91 KB