Pharmaceutical Services





Contents
    Hide details for 1. General – Biocidal products1. General – Biocidal products

A product is considered to be a biocidal product if it falls within the scope of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (BPR) for biocidal products.

Generally speaking, biocidal products are products that contain or generate active substances and are used against harmful organisms such as insects, bacteria, microorganisms, viruses, etc. Products used for plant protection do NOT fall under the category of biocidal products.

Biocidal products include household products such as disinfectants, rodenticides, insect repellents and insecticides. There are also biocidal products used in industrial applications, such as wood and material preservatives, anti-fouling paints, and embalming products to avoid damage to natural or manufactured products, disinfection of potable and non-potable water (swimming pools).

    Hide details for 2. Conditions for the authorisation of biocidal products2. Conditions for the authorisation of biocidal products
Any biocidal product marketed in Cyprus must be authorised by the competent authority, ensuring that its active substance was either approved by the European Chemicals Agency or is under evaluation for the type of product in question. If the active substance is not included in these two categories, the product cannot be authorised for marketing in Cyprus.

Biocidal products may be authorised: a) under a national procedure; b) under the mutual recognition procedure; and (c) under Union authorisation.



    Hide details for 3. How to apply3. How to apply
Union authorisation is provided via the European Chemicals Agency (ECHA).

Where the active substance has been approved, the product must be registered under the mutual recognition procedure. In order to obtain mutual recognition authorisation, an application for registration with the Register for Biocidal Products (R4BP3) must be submitted.

If the active substance is still under evaluation, it may be registered under a national procedure until the European Union has issued a decision on the active substance in question. In this case, an application for national authorisation must be submitted by filling out application form 24 (GR).

In order for a biocidal product to be approved in Cyprus, the corresponding application must be submitted (available in Greek only). The certificate provided in all cases is valid for 5 years under the Biocides Law of 2014. The time for approval depends on the time of submission of the dossier and the time the Plant Protection Products and Biocides Board meets (usually three to four times a year).

The application, together with the required certificates, may be submitted to the headquarters of the Department of Agriculture in Nicosia or electronically, by email, to the email addresses listed below. In the case of electronic submissions, the original application, together with copies of the certificates, must be delivered to the headquarters of the Department of Agriculture or sent by post.

    Hide details for 4.Certificates4.Certificates
The application must be accompanied by:
1. a Letter of Supply of the active substance from its supplier, addressed to the formulator of the product (Article 95 of the Regulation);
2. the full composition of the product, signed by its formulator;
3. the proposed label, in Greek;
4. the Safety Data Sheet concerning the product, in Greek;
5. the original authorisation from the applicant to the company responsible for placing the product on the local market to submit the application and/or pay the relevant fees.
6. proof of payment of fees ranging from EUR 50 to EUR 1 000, as applicable.
    Hide details for 5.Legislation5.Legislation
The Biocides Law of 2014 (L. 34(I)/2014) (in GR)
Regulation (EU) No 528/2012 (BPR)

Form 24 (GR)
Form 25 (GR)
Form 26 (GR)
Form 31 (GR)
Form 32 (GR)

    Hide details for 6. Contact6. Contact
Ministry of Agriculture, Rural Development and the Environment
Department of Agriculture
Agrochemical and Animal Feed Sector
1412 Nicosia
Tel.: +357 22408636
+357 22 408634
Fax: +357 22408538
Email:ahadjigeorgiou@da.moa.gov.cy
nelia@da.moa.gov.cy

7. Useful links
The Biocides Law of 2014 (L. 34(I)/2014) (in GR)
Regulation (EU) No 528/2012 (BPR)
Form 24 (GR)
Form 25 (GR)
Form 26 (GR)
Form 31 (GR)
Form 32 (GR)