Savjetovanje o odstupanju od kriterija za isključenje

Active substances meeting the following exclusion criteria should normally not be approved:

  • carcinogens, mutagens and reprotoxic substances categories 1A or 1B according to the CLP Regulation
  • endocrine disruptors
  • persistent, bioaccumulative and toxic (PBT) substances
  • very persistent and very bioaccumulative (vPvB) substances

Derogations may be possible as laid down in Article 5(2) of the BPR, when it is shown that:

  1. the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst-case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim to exclude contact with humans and release into the environment;
  2. there is evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or
  3. not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.

In this case, approval of an active substance may be granted for a maximum period of five years, and for restricted uses. In addition, Member States may only authorise biocidal products where they consider that conditions are met on their territory.

To decide if the active substance may be approved or not, a consultation is organised to collect information on whether the conditions for derogation set out in Article 5(2) of the BPR are satisfied.

During the consultation, the following information is made public:

  • substance identity (name and EC/CAS numbers)
  • product-type(s)
  • evaluating competent authority
  • a description of the representative uses presented by the applicant
  • information on the exclusion criteria met by the active substance

It is important that interested parties (manufacturers, users of biocidal products, sector concerned, authorities etc.) contribute to the consultation to collect valuable information for the decision-making process, in particular on the existence or absence of suitable alternatives.

Contributors must provide information with justifications, and not mere statements that a substance is needed or not needed.

Information collected through the consultation is made publicly available.

The European Commission together with Member States will take into account the information collected when deciding whether to approve or not the concerned active substance.

There are currently no ongoing consultations.



Kako doprinijeti javnoj raspravi?

Javna rasprava traje 60 dana.

Zainteresirane treće strane koje žele doprinijeti javnoj raspravi trebaju podnijeti relevantne informacije pomoću sigurnog mrežnog obrasca.

Za jednostavniju analizu postupka za doprinos i odlučivanje, podnositelj informacija treba učiniti sljedeće:

  • jasno navesti koja odstupanja od članka 5. stavka 2. točke (a), (b) ili (c) Uredbe BPR podnositelj smatra ispunjenima ili neispunjenima i
  • navesti detaljno obrazloženje.

Ako se istovremeno organizira javna rasprava za istu aktivnu tvar za nekoliko vrsta proizvoda, podnositelj treba podnijeti zasebne podneske za svaku vrstu proizvoda jer se odstupanje od kriterija za isključenje analizira prema pojedinačnoj vrsti proizvoda i pojedinačnoj uporabi za dotičnu vrstu proizvoda.

Podnositelj treba razmotriti i preporuke navedene u smjernicama „Podnošenje informacija za javnu raspravu o mogućim kandidatima za zamjenu u okviru Uredbe o biocidnim proizvodima“. Na primjer, kada podnositelj u svojem podnesku navede alternativne aktivne tvari koje postoje ili ne postoje, treba precizirati na koju se uporabu to odnosi, naziv i identitet alternativnih aktivnih tvari ili nekemijske metode za kontrolu ciljanih organizama, itd.

Podnesene informacije mogu biti povjerljive ili nepovjerljive. Ako smatrate da su informacije povjerljive, trebate navesti odgovarajuće obrazloženje (vidjeti smjernice „Podnošenje informacija za javnu raspravu o mogućim kandidatima za zamjenu u okviru Uredbe o biocidnim proizvodima“). Sve povjerljive informacije bit će dostupne samo za Europsku komisiju i nadležna tijela država članica.