Posvetovanje o odstopanju od meril za izključitev

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.

Trenutno ne potekajo posvetovanja.
Trenutno ne potekajo posvetovanja.
Trenutno ne potekajo posvetovanja.


Kako predložiti prispevek za javno posvetovanje?

Javno posvetovanje traja 60 dni.

Zainteresirane strani, ki želijo prispevati k javnemu posvetovanju, morajo predložiti prispevek in ustrezne informacije na varnem spletnem obrazcu.

Za omogočanje analize prispevka in postopka odločanja mora predlagatelj:

  • jasno navesti, za katera odstopanja iz člena 5(2)(a), (b) in/ali (c) uredbe o biocidnih proizvodih predlagatelj meni, da so izpolnjena ali neizpolnjena, in
  • navesti natančno utemeljitev.

Če se javno posvetovanje organizira za isto aktivno snov za več vrst proizvodov hkrati, mora predlagatelj predložiti ločene podatke za vsako vrsto proizvoda, saj se odstopanje od izključitve analizira glede na vrsto proizvoda in glede na uporabo v okviru posamezne vrste proizvoda.

Predlagatelj mora upoštevati tudi priporočila iz smernic „Submission of information in the public consultation on potential candidates for substitution under the Biocidal Products Regulation“ (Smernic za predložitev informacij v javnem posvetovanju o morebitnih možnih snoveh za zamenjavo v skladu z uredbo o biodicnih proizvodih). Če predlagatelj v svojem prispevku navede na primer obstoj ali odsotnost alternativ, mora natančno navesti uporabo, na katero se nanašajo, ime in identiteto alternativnih aktivnih snovi ali nekemijskih metod za nadziranje ciljnih organizmov itd.

Predložene informacije so lahko nezaupne ali zaupne narave. Če zahtevate zaupnost informacij, boste morali predložiti ustrezno utemeljitev (glejte „Submission of information in the public consultation on potential candidates for substitution under the Biocidal Products Regulation“ (Smernice za predložitev informacij v javnem posvetovanju o morebitnih možnih snoveh za zamenjavo v skladu z uredbo o biodicnih proizvodih)). Vse zaupne informacije bodo na voljo le Evropski komisiji in pristojnim organom države članice.

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