Understanding EU BPR

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The EU Biocidal Products Regulation (EU BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

The text had been applicable since 1 September 2013, with a transitional period for certain provisions. It will repeal the Biocidal Products Directive (Directive 98/8/EC).

What is the Product-types?

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In Annex V to the EU BPR, the biocidal products are classified into 22 biocidal product-types, grouped in four main areas. All these products with the product-types fall under EU BPR.

Table 1 Product-types fall under EU BPR

Number	Product-type
Main group 1: Disinfectants
These product types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.
PT 1	Human hygiene
PT 2	Disinfectants and algaecides not intended for direct application to humans or animals
PT 3	Veterinary hygiene
PT 4	Food and feed area
PT 5	Drinking water
Main group 2: Preservatives
Unless otherwise stated these product-types include only products to prevent microbial and algal development.
PT 6	Preservatives for products during storage
PT 7	Film preservatives
PT 8	Wood preservatives
PT 9	Fibre, leather, rubber and polymerised materials preservatives
PT 10	Construction material preservatives
PT 11	Preservatives for liquid-cooling and processing systems
PT 12	Slimicides
PT 13	Working or cutting fluid preservatives
Main group 3: Pest control
PT 14	Rodenticides
PT 15	Avicides
PT 16	Molluscicides, vermicides and products to control other invertebrates
PT 17	Piscicides
PT 18	Insecticides, acaricides and products to control other arthropods
PT 19	Repellents and attractants
PT 20	Control of other vertebrates
Main group 4: Other biocidal products
PT 21	Antifouling products
PT 22	Embalming and taxidermist fluids

Please note that EU BPR sets rules for the use of articles treated with, or intentionally incorporating, one or more biocidal products. It has had a huge impact on downstream companies of many disinfectants, preservatives, etc.

How to Comply with EU BPR?

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The compliance level of EU BPR is divided into three major parts: biocidal active substances, biocidal products and treated articles.

Biocidal active substances (AS)

• Definition of the active substance

‘Active Substance’ (AS) means a substance or a micro-organism that has an action on or against harmful organisms, such as Ethanol, Calcium hypochlorite, and Ozone generated from Oxygen.

• The existing active substance and the new active substance

Active Substances could be divided into two groups, namely the existing active substance and the new active substance.

Existing active substances are those substances that were on the market on 14 May 2000 as an active substance of a biocidal product (for purposes other than scientific or product and process-orientated research and development). The existing active substances which were identified as such and for which a notification was accepted were listed in the Review Programme. The transitional provisions laid down in Article 89 of Regulation (EU) No 528/2012 allow biocidal products containing an active substance included in the Review Programme (for a given product-type) to be made available on the market and used, subject to national rules, until three years after the date of their approval (shorter timeframes apply in case of non-approval).

New active substances are those substances that are not listed in the Review Programme for a given product-type. New active substances with the product-type should be approved before they could be placed on the EU market.

• Approval of active substances

Companies have to apply for approval of an active substance by submitting a dossier to ECHA. Studies about Phy-chemical, efficacy, human health, Ecotoxicology, environmental fate and behaviour etc. are contained in the dossier. After the validation check has been performed by ECHA, the evaluating competent authority carries out a completeness check and an evaluation within one year. The result of the evaluation is forwarded to ECHA’s Biocidal Products Committee, which prepares an opinion within 270 days. The opinion serves as a basis for the decision-making by the European Commission and the Member States. The approval of an active substance is granted for a defined number of years, not exceeding ten years.

To sum up, the approval of active substances requires more data and time. And the review decision will be issued about three years from the date of submission.

• Article 95 listing

After the first company conducts an active substance approval application, it can be automatically included in the list of Art 95. Other companies need to share costs with the first company or carry out the application for inclusion in the list of Article 95.

Applications for inclusion in the list of active substances suppliers (Article 95 list) can only be made by a legal entity established within the EU. Non-EU companies can be represented by an EU representative, for the purpose of Article 95, and be indicated on the list next to their EU representative.

Biocidal Product (BP)

• Definition of biocidal product

‘Biocidal Product’ means:

— any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,

— any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

A treated article that has a primary biocidal function shall be considered a biocidal product.

• Authorisation of biocidal products

All biocidal products must get authorisation before they can be made available on the market. Companies can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it. For example, Union authorisation could be chosen by the companies who wish to apply for an EU-wide authorisation in one go. If the product will be placed only on a single market, national authorisation from that country is sufficient. If a company wishes to place the product on the market in several countries, it can apply for mutual recognition for the product authorisation.

The data requirements of biocidal products authorization are similar to those for active substances.

• Registration or notification subjected to national laws

Biocidal products containing active substances in the Review Programme can be made available on the market and used (subject to national laws) pending the final decision on the approval of the active substance (and up to 3 years after).

Compared with authorization of biocidal products, national registration/ notification is simpler, and the timeline is shorter. For example, in Germany, to fulfil the national notification, the basic information about the products should be provided and the timeline of notification in Germany is about one week.

• Technical equivalence (TE)

The technical equivalence of an active substance needs to be assessed in the context of biocidal product authorisation when there has been a change in regard to the source of the active substance. If the substances produced from a source different to the reference source or from the reference source but following a change to the manufacturing process and/or manufacturing location compared to the substance of the reference source in respect of which the initial risk assessment was carried out, technical equivalence should be applied whether it has the similar chemical composition and hazard profile.

Treated Article (TA)

• Definition of the treated article

‘Treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

• Compliance requirements for treated articles

According to the regulation, articles can only be treated with biocidal products containing active substances approved in the EU.

Manufacturers and importers of treated articles need to ensure that products are labelled according to both the regulation on Classification, Labelling and Packaging and the additional requirements defined by the Biocidal Products Regulation.

Companies must also be ready to provide the consumers with information about the biocidal treatment of the article they are selling. If a consumer requests information about a treated article, the supplier must provide it free of charge within 45 days.

Summary

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The regular compliance requirements are listed in the table 2.

Table 2 Compliance Requirements under EU BPR

Applicant Types	Compliance Requirements	Examples of Compliance Strategy
Active substance manufacturers/ importers/ exporters	1.     Active substance is approved or under review 2.     Article 95 listing	Article 95 listing for existing active substances: Step 1. Submit enquiry to ECHA for the data owner information Step 2. Communicate with data owner and negotiate data purchasing Step 3. Purchase the Letter of Access（LoA）and collect required data Step 4. Prepare application documents and finish dossier submission
Biocidal product manufacturers/ importers/ exporters	1.      Active substance is approved or under review 2.      Article 95 listing 3.      Biocidal product is authorised or registered/notified (subject to national laws)	Product authorisation: Step 1. Determinate authorisation types and submit the technical equivalence application if needed Step 2. Conduct data gap analysis Step 3. Close data gap by testing or data purchasing etc. Step 4. Prepare dossier and risk assessment reports Step 5. Finish dossier submission
Treated article manufacturers/ importers/ exporters	It is necessary to ensure that the treated articles do not contain non-approved substances, and at the same time, compliance work, such as making labels, should be finished in accordance with Article 58 of the BPR	Treated article: Step 1. Determinate if it belongs to treated article or biocidal product Step 2. Confirm the active substance status Step3. Prepare compliance statement, labelling and efficacy data etc.

To sum up, all biocidal products require biocidal product authorisations before they can be placed on the market, and the active substances contained in that biocidal products must be previously approved. There are, however, certain exceptions to this principle. For example, Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted.

Based on the requirements and flexibility of EU BPR, different enterprises need to choose the most suitable compliance strategy according to their actual situations and requirements.

Our Services

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• Active Substance Article 95 Listing

• Active Substance Approval/Renewal Application

• Product Authorisation Application

• National Registration/ Notification subject to National Laws

• Technical Equivalence (TE) Application

• Treated Articles Compliance and labelling

• Compliance Strategy Analysis Report

• Data Gap Analysis

• Lab Screening and Test supervision

• Comprehensive Regulatory Consulting and Training

Why Choose Us?

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•  Strong Technical Strength and Background:

REACH24H has a very strong technical team specialized in global biocide/ pesticide regulatory compliance in Europe, USA, China, and South Korea for more than 10 years. 100% of our technical experts graduated with Master’s or Doctor’s degrees from prestigious universities in China and overseas Top 100 universities with professional backgrounds such as toxicology, analytical chemistry, chemical engineering, biology, pharmacology, environment and etc.

•  Outstanding Performance and Experience:

In the past ten years, we have completed almost 300 EU BPR-related projects, with an average of 97 projects completed each year. So far, we have already helped more than 200 global companies in China, Europe, the United States, South Korea, Japan, the Middle East and other areas successfully fulfil the regulatory compliance obligations under the EU BPR. With our rich experience of successful submissions of active substance approval, article 95 listing, biocidal product authorization and national registration etc., we are very skilled at providing the one-stop consulting services of EU BPR to help global clients win the Europe market rapidly.

•  Superior Resources of Authority and Laboratory:

With a decade of compliance experience, REACH24H not only has built a deep understanding of the EU BPR regulatory system and strong EU BPR service capabilities but also has developed a very good relationship with ECHA, EU National Competent Authorities, GLP labs and many task forces/associations/consortia such as IIAHC, Euro Chlor and EUOTA etc. These cooperative relationships have greatly facilitated our latest regulatory information acquisition, accurate regulation interpretation, efficient communications with enforcement authorities, and more economical and efficient compliance solutions.

Case Presentation

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Case 1: When the epidemic broke out in early 2020, there was a shortage of ethanol supply in the European Union. In order to meet the high demand of disinfectants supply in the EU market and save lives who were suffering from the virus, REACH24H took the fastest actions by fully utilizing our rich EU BPR compliance experience and our superior authorities and consortia resources to help lots of China disinfectant suppliers comply with the EU BPR requirements. Eventually, with our best effort, we successfully helped many disinfectant suppliers overcome the EU BPR regulatory compliance barriers in the shortest period of 13 working days only, which timely met the urgent needs of disinfectants in the EU market.