Act implementing the Regulation (EU) no 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products
Official Gazette, No. 39/2013, 47/2014, 115/2018 and 62/2020
Ministry of Health
Email: HELP-DESK BIOCIDI biocidi@miz.hr
Phone: +385 1 46 07 555
Web: https://zdravlje.gov.hr/
Making available on the market and use of biocidal products
Requirement laid down by Regulation (EU) no 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012)
Act implementing the Regulation (EU) no 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (official gazette “Narodne novine” no. 39/2013, 47/2014, 115/2018 and 62/2020)
Special provisions on the use of Croatian language and script in the process of approval of biocidal products
Article 7
(1) Applicant for the issuance of an European Union approval for biocidal product must deliver to the Ministry, when the Ministry is the evaluating competent authority, a summary of the properties of the biocidal product in Croatian language and Latin script.
(2) Applicant for the issuance of an approval for sequential mutual recognition of national approval for the biocidal product in the Republic of Croatia, must enclose with the application a certified translation to Croatian of the national approval of the reference European Union member state.
(3) Applicant for the issuance of the approval for parallel trade of the biocidal product, must enclose with the application for issuance of an approval a draft notification on the product (declaration) in Croatian language and Latin script for biocidal products which will be made available on the market of the Republic of Croatia.
Requirements for making available on the market and use of biocidal products in the Republic of Croatia
Article 7.a (Official Gazette 62/20)
Biocidal product can be made available on the market and used in the Republic of Croatia only if it was:
- approved in accordance with the Regulation (EU) no 528/2012 or
- approved in accordance with the procedure from Article 8.a of this Act, if it contains active ingredient from Article 89, paragraph 2 Of the Regulation (EU) no 528/2012.
Application for the issuance of national approval for biocidal product and notification on the biocidal product
Article 8
(1) Application for the issuance of the national approval for the biocidal product, application for the renewal of the national approval, application for revocation, re-examination and amendment of the national approval, application for mutual recognition of the approval for biocidal products and application for the issuance of national approval for parallel trade in biocidal product which has been approved in another member state of the European Union (“member state of origin”) shall be submitted to the Ministry in Croatian language and Latin script.
(2) The Minister decided on granting the national approval for the biocidal product, on revocation, re-examination and amendment of the national approval, on for mutual recognition of the approval for biocidal products and on national approval for parallel trade in biocidal product which has been approved in another member state of the European Union (“member state of origin”).
(3) Approval from paragraph 1 of this article shall be granted i.e. denied by virtue of decision against which an appeal is not allowed, but an administrative dispute may be initiated against this decision.
(4) Minister shall more specifically prescribe the execution of the procedure for approving biocidal products.
Approval for making available on the market and use of biocidal products which contain an active ingredient from Article 89, paragraph 2 of the Regulation (EU) no 528/2012 in the Republic of Croatia
Article 8.a (Official Gazette 62/20)
(1) Application for granting approval for making available on the market and use of biocidal product from Article 7.a, subitem 2 of this Act on the territory of the Republic of Croatia shall be submitted to the Ministry.
(2) Application from paragraph 1 of this article shall be submitted no later than 60 days before the day of approval of the active ingredient or if the biocidal products contain several active ingredients before the day of approval of the last active ingredient for that type of biocidal product.
(3) The following must be enclosed to the application from paragraph 1 of this article:
- signed formed created by completing an online form available on the website of the Ministry
- Proposed declaration in Croatian
- Safety Data Sheet
- proof of meeting the requirements from Article 95 of the Regulation (EU) no 528/2012
- proof of payment of expenses in accordance with the regulation from Article 17, paragraph 3 of this Act.
(4) At the request of the Ministry, the applicant must also deliver the samples of the biocidal products, its composition and other documentation necessary for determining the properties of the biocidal product.
(5) The Ministry decides on the application from paragraph 1 of this article by virtue of decision against which an appeal is not allowed, but an administrative dispute may be initiated against this decision.
(6) In adopting a decision, opinion of the Committee from Article 9 of this act is taken into account, which gives its professional opinion in the procedure for granting approval for making available on the market and use of biocidal product.
(7) Based on the opinion of the Committee from Article 9 of this Act on safe use and potential harmful effects on the health of humans, animals or on the environment, the Ministry may grant an approval for making available on the market and use of biocidal product and enter such product in the register or request the documentation to be supplemented.
(8) In the event of a negative opinion of the Committee from Article 9 of this Act or if the requested supplemental documentation is not delivered, the Ministry shall reject the application for making the biocidal product available on the market and for the entry of the biocidal product in the register.
(9) Approvals granted by a decision from paragraph 5 of this article shall cease to be valid in accordance with the time limits set out in Article 89 of the Regulation (EU) no 528/2012.
(10) In the approval from paragraph 5 of this article, special conditions may be imposed for making available on the market and use of biocidal product such as for example place of sale of the biocidal products, packaging size, user category and other measures aimed at reducing the risks under which the biocidal product must be made available on the market and used.
(11) If the biocidal products satisfies the criteria in accordance with the Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) no. 1907/2006 (Text with EEA relevance) (OJ L 353, 31. 12. 2008) for classification from Article 19 Of the Regulation (EU) no 528/2012, making the biocidal product available to the market for use by the general public is not permitted.
(12) In the process of granting the approval, provisions of special regulations governing the occupational health and safety, consumer protection, protection of the health of animals or environmental protection are taken into account, and if necessary, conditions in accordance with these regulations are also given in the approval.
(13) Costs of the procedure for granting approval for making available on the market and use of biocidal products shall be borne by the applicant.
Notification on biocidal product (declaration)
Article 10 (Official Gazette 62/20)
(1) Notification on biocidal product (declaration) drafted in accordance with the Regulation (EU) no 582/2012 must be in Croatian language and Latin script and it must contain an approval number from the Register of Biocidal Products of the European Union and/or classification designation of the approval.
Labelling of treated products which are to be made available on the market of the Republic of Croatia
Article 11
Notification on biocidal product (declaration) printed on the treated product in accordance with Article 58, paragraph 6 of the Regulation (EC) no 528/2012 must be in Croatian language and Latin script.
State Inspectorate
Catalogue of Croatian Standards
In the TRIS database you can look up the notification of the technical rule