Turkey BPR and OR Services

What is the Biocidal Products Regulation (BPR)?

Biocidal Products Regulation (BPR) was forced into European Union (EU) Law to regulate manufacturing, placing on the market, and usage of biocidal products.

The purpose of this regulation is to improve the protection of human health and the environment and improve the internal market’s functioning.

Biocidal Products Regulation covers the items below:

• the establishment at the Union level of a list of active substances which may be used in biocidal products;
• the authorisation of biocidal products;
• the mutual recognition of authorisations within the Union;
• the making available on the market and the use of biocidal products within one or more Member States or the Union;
• the placing on the market of treated articles.

What are the key aspects of the Biocidal Products Regulation?

• Authorisation
  The Biocidal Products Regulation requires authorization for biocidal products and their active substances before market placement or use.
• Risk assessment
  To protect human health and the environment, a risk assessment is required. This way, it is possible to foresee potential risks and take preventive measures.
• Product information
  It is also crucial to provide clear and accurate information about the product’s risks and safe use to the users to protect their health.
• Restrictions and prohibitions
  In cases where needed, the Biocidal Products Regulation may allow for restrictions or prohibitions on the safe use of certain biocidal products or active substances. This also contributes to the protection of human health and the environment.
• Market surveillance
  European Union Member States monitor the market to ensure compliance with the Biocidal Products Regulation.

Benefits of Biocidal Products Regulation (BPR)

The benefits of Biocidal Products Regulation can be divided into four main pillars. These are stated below:

• It contributes to the protection of human health and the environment.
  The Biocidal Products Regulation controls the usage of biocidal products, minimizing the risk of human contact with harmful chemicals. Biocidal substances can contaminate ecosystems. The Regulation helps to protect them from contamination with the obligations it burdens for companies. BPR also controls the use of disinfectants and other biocides, which contributes to minimising risks for human health.
• It improves market harmonisation and innovation.
  Biocidal Products Regulation fosters fair competition which leads to a consistent regulatory framework across the European Union. Furthermore, it promotes the development of biocidal products that prioritize safety and efficacy. By the effects of these benefits, product safety and efficacy are ensured and the trust among consumers increases accordingly.
• It ensures risk management and control.
  Biocidal Products Regulation requires a thorough evaluation of the potential risks related to biocidal products. This leads to better risk management. It establishes a clear and transparent procedure for the authorisation of products.

Turkish Biocidal Products Regulation (Turkey BPR)

It is widely recognized that biocidal products serve a crucial function in the management of detrimental or undesired organisms like pests and bacteria, utilizing either chemical or biological methods. On the other hand, it is important to note that these products have the potential to pose risks to both human health and the environment. The purpose of Turkish BPR is to reduce these risks and promote the safe and responsible use of biocidal products.

The scope of the BPR is broad, covering a wide array of products. These include but are not limited to disinfectants, preservatives, pest control products, and other biocidal products. The regulation controls the approval, authorisation, and usage of these products in Turkey. This makes it a crucial piece of legislation for companies that manufacture or import biocidal products for the Turkish market. The legislation in Turkey provides a detailed framework for regulating biocidal products, ensuring the protection of public health and the environment.

The content of the Turkish Biocidal Products Regulation may be summarised as below:

Title	Description
Definition and Purpose of Biocidal Products	Covers the production, import, and licensing of biocidal products before they are placed on the market, evaluating risks to human, animal, and environmental health.
Types and Categories of Products	Products specified in Annex-V; veterinary medicinal products, medical devices, and cosmetic products are excluded.
Active Substances and Uses	Active substances used in biocidal products are approved for specific uses and listed in List I, List A or List IA.
Conditions for Production, Import, and Marketing	Necessary permissions must be obtained, and specified conditions must be met for the production, import, and marketing of biocidal products.
Licensing and Registration Processes	The application process, required documents, and timelines for licensing and registering biocidal products are detailed in the regulation.
Packaging and Labelling Requirements	Packaging and labelling of biocidal products must comply with the Regulation on Classification, Labelling, and Packaging of Substances and Mixtures.
Inspection and Notification Obligations	Post-market inspections of biocidal products, preparation of safety data sheets, and notification processes to the national poison control centre are included in the regulation.

How to comply with the Turkish Biocidal Products Regulation?

Steps to comply with the Turkish Biocidal Products Regulation are as below:

• Regulation and definitions
  To achieve compliance with the Turkish Biocidal Products Regulation, the initial and crucial step is to acquire a comprehensive understanding of the associated terminology and concept. Without the required knowledge, the coverage of the regulation and its related definitions will be probably misunderstood which leads to a failure in the compliance process.
• Product registration and notification
  For a biocidal product to be marketed in Turkey, it must be registered with the related authority. The process of product registration and notification includes the steps below:
  • An application dossier including the chemical composition, usage instructions, label information and safety data must be prepared.
  • It is necessary to evaluate the potential risks of the product on both human health and the environment.
  • All the safety information related to the product must be detailed with safety data sheets.
• Labelling and packaging
  Turkish Biocidal Products Regulation establishes certain rules on the labelling and packaging of biocidal products. According to these rules, labels should include information such as product content, usage instructions, storage conditions, and risk information. Furthermore, the packaging must meet the requirement of being safe and leak-proof.
• Manufacture and Good Manufacturing Practices (GMP)
  Manufacture of biocidal products should be completed in accordance with Good Manufacturing Practices (GMP). This includes applications of standardised procedures for ensuring quality and safety in every step of the manufacturing process.
• Storage and transportation
  In the event of storage and transportation of biocidal products, the rules stated in the regulation must be followed. The purpose of creating these rules is to ensure the quality and safety of the products.
• Market surveillance and audit
  The regulation requires biocidal products to be audited continuously in the market. The purpose of these audits is to review the product samples that will be analyzed in the laboratory and assess the accompanying documentation.
• Updates and information
  Regular compliance with regulatory changes and updates is necessary. It is essential that both the users and other shareholders are fully informed about the safe usage of biocidal products.

By following the steps above, compliance with the Turkish Biocidal Products Regulation can be accomplished.

What is the timeline for the registration procedure?

The timeline for the Turkish registration procedure is stated below:

Details of the step	Responsible Part	Time (working days/working weeks)
• Review of the provided document/information • Asking for further information if required after the review of the provided documents/information	Chemleg	2-3 weeks
• Responding Chemleg’s amendment requests for the documents	Manufacturer	***
• Preparation/submission of the registration dossier	Chemleg	4-8 weeks
• Delivery of the hard copies of certain documents generated by the manufacturer	Manufacturer	***
• Evaluation of the dossier by the CA • Tracking of the registration dossier situation	MoH/Chemleg	4-8 months (This is the first response time of authority. Then the process might continue based on the authority requests.)
• Approval of the registration dossier	MoH	***

Only Representative Services

Compliance with the BPR is not optional; it is a legal requirement. Turkish Biocidal Products Regulation requires manufacturers and formulators to have a legal entity in Turkey. This is not a feasible option for numerous foreign companies, therefore they must designate an Only Representative. Only representatives assume the responsibilities of foreign manufacturers and formulators. They make sure to comply with BPR and other applicable Turkish regulations.

To ensure compliance with BPR, they undertake various tasks, including applying for biocidal product authorisation, managing data, and communicating with Turkish authorities. They also monitor regulatory updates and ensure compliance with the current legislation.

Benefit from our Turkey BPR OR Services

To conclude, apart from being a regulatory requirement, there are several advantages for foreign companies who wish to enter the Turkish market by appointing an Only Representative. If you need support with your biocidal product processes, you can reach out to us for assistance.

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