EU Product Registration

Product Registration

Biocidal Products

Biocide regulation refers to the biocidal active substance and the biocidal product. The biocidal active substances are mostly chemical compounds, but can also be microorganisms (e.g. bacteria). Biocidal products contain one or more biocidal active substances and may contain other non-active ingredients intended at synergistic effects or to produce physical characteristics like color or pH.

Plant Protection Products

Plant Protection Products (PPP) require authorisation/registration in the EU. The EU has developed a regulatory framework through Regulation (EC) 1107/2009 which lays down rules for the authorisation of Plant Protection Products (PPPs). The Regulation requires extensive risk assessments to be carried out before PPPs can be placed on the EU market and used. This process involves all Member States, the European Food Safety Authority (EFSA), and the European Commission (Commission).

Biocidal Products

Biocide regulation refers to the biocidal active substance and the biocidal product. The biocidal active substances are mostly chemical compounds, but can also be microorganisms (e.g. bacteria). Biocidal products contain one or more biocidal active substances and may contain other non-active ingredients intended at synergistic effects or to produce physical characteristics like color or pH. 

Biocidal products manufactured or imported into the EU require a product authorisation. Product authorisation is an equivalent term for ‘registration,’ and is granted by each EU member state where the product will be used or sold. The Biocidal Product Regulation (BPR, EU Regulation (EU) 528/2012) and its delegated acts set out a regulatory framework for a harmonized approach to active substances approval at the EU level, and national authorisation procedures for Biocidal Products in the EU.

What is regulated?

  • The Active Substance (AS) used in Biocidal Products (BPs) or placed on the EU market alone must be listed on the Union list of approved active substances in combination with its specific use, or alternatively, present in the list of substances in the ongoing active substances review programme in combination with its specific use. In order for an active substance to be included on the Union list (formerly Annex I of Directive 98/8/EC), the supplier of the active substance or the producer of the Biocidal Products containing the active substance must submit an application to ECHA. 
  • After the active substance is approved for a specific Product Type (PT), the supplier then needs to apply for authorisation for its Biocidal Products before it can be made available on the market. There are twenty-two biocidal product types (PTs) and the description of each PT is found in the Annex V of the BPR. It is essential to identify the specific product type for any biocidal product in order to determine compliance requirements.

Product Types

Information requirements for active substances approval and for biocidal product authorisation are found in the Annex II and Annex III of the BPR, respectively.

  • In addition to active substance approval and national authorisation requirements, producers and/or importers of Biocidal Products in the EU must refer to the Article 95 active substance suppliers list and make sure that their suppliers are included in the list. The Article 95 list includes the identity of suppliers and product type of each active substance, for which a complete substance dossier has been submitted and accepted under the provision of the BPD. Biocidal producers and importers had until 1 September 2015 to comply with the Article 95 requirements. A supplier of an active substance or a representative of a non-EU active substance supplier must submit a dossier or a letter of access to ECHA in order to be included in the Article 95 list. 

Nanomaterials and articles that have been treated with biocidal product(s) are covered within the scope of the BPR. These types of products are subject to the active substance approval and national authorisation. 

What must be submitted?

The BPR provides several options to obtain national authorisation. When a supplier intends to place a biocidal product in more than one member state, the supplier can select from the following authorisation options based on the application time and the overall cost that it can bear.

  • Union authorisation
  • Mutual recognition in parallel
  • Mutual recognition in sequence

Union authorisation offers a product authorisation that will be effective throughout the EU market without the supplier applying to any specific member state.

For authorisation through mutual recognition (whether in parallel or in sequence), the supplier must first identify the member states where the biocidal product will be sold and choose one competent authority to conduct the evaluation.

For mutual recognition in parallel, the evaluation is conducted by the chosen competent authority and other concerned member states can engage in the evaluation process simultaneously by providing comments.

Mutual recognition in sequence grants an authorisation for one country and other member states are asked by an applicant to recognize the authorisation.

Submission of information

For the approval of the active substance the Active Substance dossiers are to be created using IUCLID and submitted via the Register for Biocidal Products (R4BP). 

For the product authorization a Product Dosser is to be created in IUCLID and a Summary of Product Characteristics (SPC) is to be compiled via the SPC editor, which is required for each national authorisation. The product dossier(s) and the SPC are then submitted to ECHA through R4BP. ECHA has published numerous guidance documents to clarify the components of the BPR, and they are available from its website.

Transitional Period

The Biocidal Product Regulation, which came into force on 1 September 2013, provides transitional measures in which each EU member state is allowed to enforce its own laws and regulations to control Biocidal Products before adopting the BPR measures in full. Consequently, suppliers of Biocidal Products may be required to comply with existing national authorisation procedures unique to the member state.

Treated Articles

Articles can only be treated with active substances that have been approved under the biocide regulation for that purpose (specific product category). The regulation also includes labeling requirements for articles that have been treated with or incorporate a biocidal product in case

  • a claim is made that the treated article has biocidal properties; or
  • the active substance used to treat the article is subject to specific labelling provisions as part of it’s approval

Consumers can request information from the supplier on the biocidal treatment applied to the article. This information needs to be provided free of charge within 45 days.

Plant Protection Products

Plant Protection Products (PPP) require authorisation/registration in the EU. The EU has developed a regulatory framework through Regulation (EC) 1107/2009 which lays down rules for the authorisation of Plant Protection Products (PPPs). The Regulation requires extensive risk assessments to be carried out before PPPs can be placed on the EU market and used. This process involves all Member States, the European Food Safety Authority (EFSA), and the European Commission (Commission).

Registration

EU Regulation (EC) No 1107/2009 lays down harmonised rules for the approval of an active substances and the placing on the market of Plant Protection Products (PPPs). The Regulation requires a risk assessments to be carried out before the active substance can be placed on the EU market and used. 

  • The initial dossier is submitted by the applicant to one of the EU countries which will be responsible for an initial evaluation. This Rapporteur Member State (RMS) prepares a draft assessment report within 45 days of dossier receipt (for applicants that pass admissibility checks) to be evaluated by the European Food Safety Authority (EFSA). Excluding confidential information, the EFSA then makes the summary dossier publicly available for comment.
  • The RMS conducts its evaluation which is to be completed within 12 months of the dossier completeness notification. RMS can request additional information at this time, allowing for a “Stop the Clock” with a maximum of 6 months, allowing for data provision. A Draft Assessment Report (DAR) is submitted by the RMS to the Commission and the EFSA. The EFSA must circulate the DAR within 30 days, allowing for a 60 day comment period. The EFSA must adopt their conclusion within 150 days after the commenting period. EFSA can request a “Stop the Clock” (90 day additional data provision and 60 day evaluation of new data). 
  • At this time the EFSA provides their conclusion to the Commission, which provides their Review Report (within 6 mo.) to the Standing Committee which then makes the final decision on approval or non-approval.
  • Once approved, the Regulation and Review Report, date of entry into force and any conditions are established and published in the Regulation in the EU official Journal.

If the substance is approved it will be added to the Pesticide Database on active substances. Active substances are approved for a maximum time of 10 years. After that time the approval needs to be renewed.

More information on the responsible authorities can be found under the Member States.

The Plant Protection Product authorisations should be submitted via the European Commission’s Plant Protection Products Application Management System (PPPAMS). The relevant Rapporteur Member State is responsible for evaluating the application in the system. The PPPAMS is used in addition to the other electronic and manual processes of the Member States.

PPP Label 

The label of a PPP must include safety information in a text box on the front or main panel of the products, with the heading “Safety Information.” This text box must be placed in a prominent position and cover a significant proportion of the main panel area and display the hazard statements, precautionary statements, pictograms and signal words stipulated by CLP Regulation (EC) No 1272/2008.

  • Hazard Statements must appear each on a separate line and in bold, in sentence case (not capitalised).
  • Precautionary Statements must be listed under the Hazard Statements; each on a separate line; and, in normal font, except for phrase EUH401: “To avoid risks to human health and the environment, comply with the instructions for use”.

Consumer products, not intended for professional use must display the following Precautionary Statement Codes listed under Annex IV of the CLP Regulation:

  • P102: Keep out of reach of children
  • P103: Read label before use

Pictures, graphics or other statements portraying the product as “Harmless”, “Non-Toxic” or “Safe to children and / or pets” cannot be included in the same text box. These should appear together with any other information concerning the use of the product in another less prominent position on the label.