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.

• Previous consultations

Kif tissottometti kontribuzzjoni għall-konsultazzjoni pubblika?

Il-konsultazzjoni pubblika ddum 60 jum.

Il-partijiet interessati li jixtiequ jikkontribwixxu għall-konsultazzjoni pubblika għandhom jissotomettu l-kontribuzzjoni u l-informazzjoni rilevanti bl-użu ta’ formola elettronika sikura.

Biex tiġi ffaċilitata l-analiżi tal-kontribuzzjoni u biex jiġi ffaċilitat il-proċess tat-teħid ta’ deċiżjoni, dak li qed jagħmel is-sottomissjoni għandu:

• jindika b’mod ċar liema deroga tal-Artikolu 5(2)(a), (b) u/jew (ċ) tal-BPR dak li qed jagħmel is-sottomissjoni jqis li ntlaħqet, u
• jipprovdi ġustifikazzjoni ddettaljata.

Meta tkun organizzata konsultazzjoni pubblika dwar l-istess sustanza attiva għal diversi tipi ta’ prodott fl-istess ħin, dak li jkun qed jagħmel is-sottomissjoni għandu jipprovdi sottomissjonijiet separati għal kull tip ta’ prodott, billi d-deroga għall-esklużjoni hi analizzata għal kull tip ta’ prodott, u għal kull użu fi ħdan it-tip ta’ prodott.

Dak li qed jagħmel is-sottomissjoni għandu wkoll jikkunsidra r-rakkomandazzjonijiet previsti fil-gwida dwar “Is-sottomissjoni ta’ informazzjoni fil-konsultazzjoni pubblika dwar kandidati għas-sostituzzjoni skont ir-Regolament dwar il-Prodotti Bijoċidali”. Pereżempju, meta dak li jkun qed jagħmel is-sottomissjoni jindika l-eżistenza jew l-assenza ta’ alternattivi fil-kontribuzzjoni tiegħu, hu għandu jkun preċiż dwar l-użu li qed jirreferi għalih, l-isem u l-identità ta’ sustanzi attivi alternattivi jew metodi mhux kimiċi biex jiġu kkontrollati l-organiżmi fil-mira eċċ.

L-informazzjoni sottomessa tista’ tkun mhux kunfidenzjali jew kunfidenzjali. Jekk tiddikjara li l-informazzjoni hi kunfidenzjali, inti trid tipprovdi ġustifikazzjoni xierqa (ara l-gwida dwar “Is-sottomissjoni ta’ informazzjoni fil-konsultazzjoni pubblika dwar kandidati għas-sostituzzjoni skont ir-Regolament dwar il-Prodotti Bijoċidali”). Kull informazzjoni tkun disponibbli biss għall-Kummissjoni Ewropea u għall-awtoritajiet kompetenti tal-Istati Membri.