illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.


Biocidal products are used to control unwanted organisms that are harmful to human or animal health or to the environment, or that cause damage to human activities. These harmful organisms include pests (e.g. insects, rats or mice) and microorganisms (e.g. bacteria, viruses, mould).

Biocidal products include among others:

  • Insecticides (except those used for plant protection purposes which are regulated by Regulation (EU) No 1107/2009)
  • Insect repellents
  • Disinfectants
  • Preservatives for materials such as wood, plastics and fibres
  • Anti-fouling paints for the protection of ship hulls.
    They play an important role in EU citizens’ daily lives, for example, helping to protect against:
  • Vector-borne diseases (e.g. malaria, dengue fever or chikungunya)
  • Food-borne diseases (e.g. salmonellosis, listeriosis)
  • Hospital-acquired infections (e.g. MRSA).

They are also widely used in materials such as plastics, paints, textiles, wood, etc. to protect these materials against microbial, fungi or insect decay.

However, because of their intrinsic properties, biocidal products can pose risks to humans, animals and the environment. As a result, the EU has set up strict rules and procedures to minimise these risks.

The Biocidal Products Regulation (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.

All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. There are, however, certain exceptions to this principle.

The BPR aims to harmonise the market at Union level.

As in the previous directive, the approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level. This authorisation can be extended to other Member States by mutual recognition. However, the new regulation also provides applicants with the possibility of a new type of authorisation at Union level (Union authorisation).


  • Compliance with BPR
  • Local requirements
  • Application for active substance or biocidal product
  • Responsible person for chemicals (“Svetovalec za kemikalije”)
  • Registration of a company for manufacturing, storage, and marketing of dangerous chemicals

For medical consultancy you need a lot of experience.


Brajdih Čendak

Medical Doctor Medical Advisor & QPPV Deputy