HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Directorate E – Food and feed safety, innovation
E4 - Pesticides and Biocides
66thmeeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
Subject:Proposal for the management of active substances which are food or feed for which declarations of interest to notify were submitted under Article 15(b) of Regulation (EU) No 1062/2014
The purpose of this document is to present a proposal on the management of food and feed active substances which benefited from the derogation provided for by Article 6 of Regulation (EC) No 1451/2007, and for which declarations of interest to notify were submitted to ECHA by 30 October 2015 and declared compliant.
The following proposal was endorsed during the 66th CA meeting.
1- Background and proposal
- Overview and timings
Under Article 15(b), Regulation (EU) No 1062/2014 ("the Review Regulation") provided companies with an opportunity to support those active substances that benefitted from the food and feed derogation provided for by Article 6 of Regulation (EC) No 1451/2007. A declaration of interest to notify had to be submitted to ECHA by 30 October 2015.
ECHA has now finalised the review of these declarations and concluded on their acceptability or refusal, which has been communicated to the related submitters. These conclusions have been made publicly available on the ECHA website on the accepted ones[1].
Where no declaration of interest to notify was submitted by October 2015, or when it was submitted but rejected, the related biocidal products shall no longer be made available on the EU market on 30 October 2016 andshall no longer be used by 30 April 2017, as provided under Article 21(1) of the Review Regulation.
Where a declaration of interest to notify has been accepted by ECHA, any person with an interest to notify the substance/product-type combination may do so pursuant to Article 17 of the Review Regulation within 6 months of the publication to ECHA (ie. by24 February 2017).
Active substances for which notifications will be submitted and declared compliant by ECHA will be included in the review programme pursuant to Article 18 of the review Regulation.
- Screening for Annex I inclusion
During its assessment of the declarations of interest to notify, ECHA examined whether the concerned food and feed were active substances within the meaning of the BPR in order to define whether the declaration of interest to notify could be accepted (as it concerned a substance), or had to be rejected (because the concerned food or feed was not in the scope of the BPR[2], or the concerned food or feed were mixtures and not substances).
More specifically, ECHA was able to identify active substances thatmight be suitable candidates for inclusion into Annex I to the BPR, as they would not give rise to concern in accordance with Article 28(2) of the BPR. It is important to remind that the concerned substances are food and feed used as active substances for PT19, like honey, fructose or malt extract. This analysis is provided in Appendix to this document, and represents a preliminary screening based on a consultation of the Classification and Labelling Inventory and the information provided in the declarations.
2- Proposal
The "normal" process for the review of these active substances would be to go through the submission of an application to require the approval or annex I inclusion to the BPR.
Nevertheless, considering that:
(1)these active substances are food and feed used for PT19 "repellent or attractant";
(2)theyhave been placed on the EU market and used so far in biocidal products;
(3)a declaration of interest to notify was submitted in time by companies on these active substances;
(4)some of these active substances might be suitable candidates for inclusion into Annex I to the BPR;
(5)none of these substances are currently under examination in the review programme in a Member State;
(6)building and processing a dossier to request the approval or inclusion into annex I would request some resources from both companies and authorities, in a context where many active substances are already in the review programme set in Annex II to the Review Regulation. Also, as other active substances will soon be added in the context of the in situ generation time and resources might be spent more effectivefor safeguarding health and environment by assessing other substances and substances under exclusion/substitution;
the Commission and ECHA are of the opinion that a simplifiedprocess could be possible on these food and feed substances which may be eligible to Annex I inclusion.
It wastherefore agreed during the 66th CA meeting that:
(a)The Commission formally requestsan opinion to ECHA under Article 75(1)(g)of the BPR as to whether some of these food and feed active substances could be eligible to Annex I inclusion. ECHA will organise its work with the BPC. Based on the ECHA opinion, the Commission is empowered to adopt a delegated act to include the eligible substances into Annex I to the BPR pursuant to Article 28(1) of the BPR. As no dossier would have been submitted by an applicant, no data protection is needed and the related substances could go, when appropriate, under category 4 "Traditionally used substances of natural origin", category 1"Substances authorised as food additives according to Regulation (EC) No 1333/2008 " , or as a last resort, category 7 "Other". The entry would not be restricted to PT19 use, and the substance would be allowed to be potentially used for any PT.
(b)In parallel, companies should nevertheless still follow the normal regulatory processof submitting notifications at the latest 6 months after the publication of the acceptance of the declaration of interest to notify, in order to be included the Review Programme and secure the making available on the market and use of related products.
Once the notification is accepted, a period of 2 years is foreseen under Article 3(2) of the Review Regulation for the submission of the application on the active substance: during this 2 years period, it is expected that the opinion of ECHA will be delivered and, for those substances eligible for Annex I inclusion, the formal decision of inclusion be taken, removing the need to submit an approval/inclusion dossier on the active substance. Products containing the related active substance will be allowed to go through the simplified authorisation procedure as from the date of amendment of Annex I to the BPR.
For the other substances not found eligible in the ECHA opinion, the normal process will have to carry on with the submission of the application for approval in due time.
The Commission would like to point out that this specific proposal is exceptional and a one-off exercise for food and feed substances for which declarations of interest to notify were found compliant under Article 15(b) of the Review Regulation. Any company interested in other substances which could be potential candidate to Annex I inclusion has to go through the normal process established under Regulation (EU) No 88/2014.
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Appendix – Preliminary screening
Results of declarations of interest on food and feed under Article 16(1)(b) of Regulation (EU) No 1062/2014 (source : ECHA)
Table 1 and 2 list the substances open for notification in accordance with Article 17 of Regulation (EU) No 1062/2014 following publication on the ECHA website on August 24. The list is split into two as different paths are proposed:
-Table 1 presents the list of substances that are considered suitable candidates to be included in Annex I of the BPR;
-Table 2 on the other hand, presents the substances that are probably not candidates to be included in Annex I of the BPR;
The inclusion of the different substances in either Table 1 or 2 is based on the information submitted in the declaration, the Classification and Labelling Inventory (several substances in table 2 are self-classified as skin sensitizers) and expert judgment.
Table 1.List of substances open for notification considered suitable candidates to be included in Annex I of the BPR.
Active substance / EC/List number / CAS numberα-Lactose monohydrate / 611-913-4 / 5989-81-1
Apple juice concentrate (food grade) / NA / NA
Brandy (food grade) / NA / NA
Cheese / NA / NA
Fructose / 200-333-3 / 57-48-7
Honey / 617-041-0 / 8028-66-8
Fulvic acid / 610-395-7 / 479-66-3
Malt, ext. / 232-310-9 / 8002-48-0
Peanut butter / NA / NA
Powdered egg / NA / NA
Saccharomyces cerevisiae, ext. / 283-294-5 / 84604-16-0
Skimmed milk powder / NA / NA
Vinegar
(food grade containing a maximum of 10% acetic acid) / 290-419-7 / 90132-02-8
Yeast (food grade) / NA / NA
Table 2. List of substances open for notification considered not suitable candidates to be included in Annex I of the BPR.
Active substance to be listed / EC/List number / CAS number / Reason for non-eligibility to Annex I - C&L InventoryCapsaicin / 206-969-8 / 404-86-4 / Acute toxicity 3, skin sensitisation, respiratory sensitisation and STOT SE 3
Lemon oil / 616-925-3
617-036-3 / 8008-56-8 / Skin sensitisation and aquatic acute 1
Garlic, ext. / 232-371-1 / 8008-99-9 / Acute toxicity 3 and skin sensitisation
Mentha arvensis, ext. / 290-058-5 / 90063-97-1 / Skin sensitisation and aquatic acute 1
Orange, sweet, ext. / 232-433-8 / 8028-48-6 / Skin sensitisation, STOT SE 3, and aquatic acute 1
Pepper (Piper), P. nigrum, ext. / 284-524-7 / 84929-41-9 / Acute toxicity 3, skin sensitisation and aquatic acute 1
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[1]
[2]Food or feed which are neither substances nor mixtures (nor micro-organisms) are not in the scope of the BPR, similarly to dried lavender blossoms (Decision (EU) No 2016/678)