EBPF – European Biocidal Products Forum
POSITION PAPER
19 January 2017
An interim approach for the establishment of maximum residue
limits for residues of active substances contained in biocidal
products for food and feed and specific migration limits in food
contact materials (CA-Nov16-Doc.7.4.b) – Industry proposal for
establishing Maximum Levels
A.I.S.E. and EBPF (a Sector Group of Cefic) propose setting of Maximum Levels by
EFSA upon biocidal product authorisation on the basis of the available hazard
evaluation of active substances, while keeping the monitoring phase for allowing
later refinement when relevant. Industry believes that this will guarantee
consumer protection and facilitate the enforcement by authorities.
We ask the Commission and Member States Competent Authorities to agree on
this proposed way forward.
Background
At the 65th biocides Competent Authorities (CA) meeting (16-18 November 2016), the European
Commission/DG SANTÉ (COM) presented its updated note for discussion on Maximum Residue Limits
(MRL) to the competent authorities for biocidal products. Its purpose is to develop a policy approach for
the establishment of Maximum Levels of biocidal active substances in food and feed and specific
migration limits from food contact materials.
Further to the on-going discussions, we appreciate the opportunity to submit herewith additional
comments and a proposal for establishing Maximum Levels.
Introduction
The last COM proposals have been moving towards a requirement for monitoring levels of residues in
food after active substance approval. Based on the collected monitoring data, Maximum Levels may be
set in those cases where ‘significant’ levels are found in food. The use of the term “significant” not only
introduces vague language and uncertainty, but may also lead to subjective and divergent interpretation
by individual Member States and Applicants.
According to the COM proposal, Maximum Levels can only be set later in the process, at biocidal product
authorisation stage, after the monitoring phase. This, the likelihood of expert discussions, and potential
disagreements on the significance of levels found in food are likely to lead to unnecessary delays in the
authorisation process and will not make the best use of time and resources by both Member States and
Applicants.
EBPF – European Biocidal Products Forum
Furthermore, the proposed COM approach may lead to very low levels that will not help managing
biological incidents with using higher biocide use concentrations. The approach would immediately
result in identifying levels in food above the Maximum Level set. Also new uses, extended uses, and even
possibly the same use in other circumstances (different machines, food/surface ratios) might not be
practically possible once a Maximum Level is set in accordance to the proposed COM approach. In such
cases it will be difficult to modify the Maximum Level to a value that is ‘fit for purpose’, but also reflects
best practice and ensures that all the uses of the biocidal product pose no risks to consumer.
Industry understands Member States’ concerns with the proposed COM approach vis-à-vis enforcement.
We agree that there are no means for enforcements before establishing the need to set a Maximum
Level and/or setting a Maximum Level. This leads to a period of uncertainty of whether uses and
resulting levels in food of the biocidal product are actually safe or not.
Industry proposal for establishing Maximum Levels
Upon authorisation of biocidal products, Maximum Levels shall be set for all biocidal active substances
with the potential leading to residues in food based on the hazard profile of the biocidal active
substances. As the full hazard profile is available, but information on actual levels in food is generally not
available, we propose to set a Maximum Level based on the ADI1 of the active substance.
As the Maximum Level is based on the assumption on residue levels in all foods that are in principle
ready for consumption, no discussion on processed foods or processing factors is needed and the final
food to be consumed should also be compliant to that Maximum Level.
We believe this approach has several advantages. This way forward:
1. Guarantees consumer safety
2. Facilitates the enforcement by authorities
3. Allows establishing Maximum Levels already during the active substance approval and not later,
after a monitoring period.
4. Clarifies that the responsibility and accountability lies with the users of the Biocidal Product who
have to assure that the processed food is safe for biological contamination and that biocide
levels are in accordance to their intended uses and in line with compliance criteria set by the
Regulatory authorities.
5. Ensures a level-playing field on the biocides market as it would not lead to a preference for using
a biocidal product for which a Maximum Level has not been set over another for which a
Maximum Level has been set.
6. Allows the refinement of the Maximum Level when significant levels are found which are not in
line with best practice of biocides, by keeping the monitoring phase as proposed in the COM
policy paper.
1
Recently, the ADI and ARfD derivation for biocidal active substances has been agreed at Human Health Working Group meeting
(WG-V-2016) and is publicly available on ECHA website: https://echa.europa.eu/about-us/who-we-are/biocidal-productscommittee/working-groups/human-health. According to this document, and in order “to align with the principles applied in the
plant protection products framework, these (i.e. ADI ADI and, if necessary, ARfD) reference values should always be derived if
appropriate information is available, unless it is not scientifically justified (e.g. highly reactive substances where no residues are
expected).” This is valid for all Product Types.
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EBPF – European Biocidal Products Forum
Considering the above explanation we hope that our proposal will be agreed by the Commission and
Members States. This will help both Member States and Applicants to address this complex issue in a
timely manner and ensure the protection of the consumer.
For more information please contact:
Camelia Mihai
+32 2.792.75.03; [email protected]
For more information please contact:
Dave Dillon
+32 2.679.62.84; [email protected]
About EBPF
The European Biocidal Products Forum (EBPF) is a sector
group of Cefic, composed of more than 70 companies and
trade associations representing the industry that places a
wide range of biocidal products on the market for the benefit
of EU citizens.
About A.I.S.E.
A.I.S.E. is the voice of the Soaps, Detergents and Maintenance
Products industry in Europe. Its membership totals 31
national associations, covering about 900 companies ranging
from small and medium-sized enterprises to large
multinationals. Biocidal products manufactured by A.I.S.E.
members include a vast range of disinfectants for household
and institutional use, as well as household insect control
products.
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