CA-May15-Doc.7.3.a

UK CA Comments on Maximum Residue Limits under the Biocidal Products Regulation

Issue

Discussion has started on the topic of establishment of maximum residue limits under the Biocidal Products Regulation (BPR), in particularat the December 2013 Biocides Competent Authorities meeting[1] and at the MRL Conference held at the BfR, Berlin in March 2014. However, we believe further consideration and work is still required.

Article 19 of the BPR deals with the conditions for granting authorisation of biocidal products. One of these conditions, at subparagraph (1)(e), states that ‘where appropriate maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product….’ (emphasis added)

During the negotiations of the BPR the UK was satisfied with this addition due to the presence of the words ‘where appropriate’ and ‘limits’, which we believed would restrict the application of this concept only to situations where statutory residue limits are necessary to protect human health.

We are concerned however that the discussions regarding maximum residue limits are not giving due consideration to these important constraints. Industry has also raised similar concerns in their follow-up comments from the MRL Conference in Berlin.[2]

Maximum Residue Limits and Levels

There is a subtle yet significant difference between the definition of a maximum residue limit, as adopted by the veterinary medicine regime and referred to in the BPR, and amaximum residue level, as adopted by the Plant Protection Products (PPP) regime.

According to Article 3(2)(d) of Regulation (EC) No. 396/2005[3] for PPPs a maximum residue level means ‘the upper legal level of a concentration for a pesticide residue in or on food or feed…based on good agricultural practice[4] (GAP) and the lowest consumer exposure necessary to protect vulnerable consumers’.

In other words, they are legal limits on pesticide residues in food and are the maximum residue levels that can be found in food after it has been treated with a pesticide, assuming that the user applied the pesticide according to its label conditions and GAP.

Maximum residue levels are not safety limits.In fact they are set below safety limits. An exceedance indicates that the user may not have used the pesticide according to its label; did not follow GAP; or the food concerned originated from outside the EU, and is not compliant with the EU maximum residue levels. It does not necessarily mean however that there are any associated consumer intake concerns. Exceedances may lead to residues that are significantly below the Acceptable Daily Intake[5] (ADI) and the Acute Reference Dose[6] (ARfD).

According to Article 1(1)(b) of Regulation (EEC) No.2377/90[7] for veterinary medicinal products (VMP), a maximum residue limit means ‘the maximum concentration of residue resulting from the use of a VMP…which may be accepted by the Community to be legally permitted or recognised as acceptable in or on a food’.

Maximum residue limits reflect a ‘safe’ level of residue following the administration of a VMP. Calculating maximum residue limits for VMPs uses the ADI for the active substance in question. Unlike for maximum residue levels, the exceedance of a maximum residue limit is cause for concern in terms of risk to human health.

To ensure that the establishment of maximum residue limits under the BPR is proportionate and does not overburden a regulatory system that is already under resource pressure, the UK CA would strongly argue that ‘where appropriate’ should pertain to situations where consumers are potentially being put at risk from unacceptable levels of active substance residues. As with the VMP regime, it would be pragmatic to establish risk-based maximum residue limits (rather than levels)for active substances, case-by-case, and only when consumer safety is jeopardised.

‘Dual use’ active substances

We nevertheless note that Article 3(1)(c) of 396/2005 defines ‘pesticide residues’ as residues of active substances which may arise as a result of use in a PPP and as a biocide –so-called ‘dual-use actives’. As a resultcertain biocidal active substances already have a statutory maximum residue level as set under this Regulation.

A number of these dual-use actives are also subject to the default maximum residue level of 0.01mg/kg (i.e. limit of determination[8], LOD) as set under 396/2005.

This default is applied to actives for which EU harmonised maximum residue levels or temporary maximum residues levels (non-harmonised levels based on levels set by member states before the coming into force of regulation 396/2005)do not exist.

As such, thisdefault is an arbitrary level established at a very low precautionary level in the absence of evidence.

It is unclear whether due consideration was given to the differences between the PPP and biocides regimes, when incorporating biocidal active substances into 396/2005.This regulation of dual-use active substances has already caused a number of issues for DG SANTE and Member States – for example the application of the default maximum residue level of 0.01mg/kg to BAC and DDAC (quaternary ammonium compounds (QUATs)) under 396/2005. We are also aware of a similar situation regarding the dual-active, chlorate, which is currently under scrutiny by DG SANTE.

In 2012 the Commissionwas informed by food business operators and certain Member States that various food products contained QUATs residue levels above the default, and that these exceedances were due to a biocidal use of the active substances in disinfectants, rather than PPP use.

Dietary risk assessments performed by the BfR using the European Food Standards Authority (EFSA) PRIMO model indicated that the default level was not a health standard and this led to the introduction of an elevated temporary maximum residue level of 0.5mg/kg. Evaluations showed that this level was adequate to protect human health. Following further monitoring of QUAT residue levels by various Member States and evaluations by EFSA and the DG SANTEa revised statutory maximum residue level of 0.1mg/kg was set for QUATs.[9]

This example demonstrates how the use of a default set at the LOD may be inappropriate for the biocidal use of active substances.Further, the 6 June 2014 paper submitted jointly by the UK Chilled Food Association (CFA) and British Association for Chemical Specialities (BACS) illustrates why setting defaults at the LOD would not be practicable for many reasons e.g. difficulty that many labs have in detecting residues at these low levels, cost of equipment for industry, etc.

The CFA/BACS paper also highlights that certain parts of the PPP regime would not translate to biocides e.g. GAP, PPP matrix types (i.e. mainly raw agricultural commodities).

We also note that the revaluation of the maximum residue levels for dual-use actives has been a long and complex process lasting approximately two years – asituation that has increased the burden on DG SANTEand Member States and has created a great deal of uncertainty for industry.

It would be undesirable toreplicate this position under BPR, particularly at a time when Commission and Member State efforts are concentrated on completion of the review programme.It has proved difficult to ‘relax’ limits in the past, and this may have resulted in a significant level of enforcement action which may subsequently prove to have been unnecessary.

The regime for setting maximum residue levels for PPP has a longand complex history. Since 1976, more than 45,000 European Community (EC) maximum residue levels have been set for various commodities for 245 pesticides on fruit and vegetables, cereals, and foodstuff of animal origin. For the tens of thousands of pesticide/commodity combinations for which no EC maximum residue levels existed, Member States could set their own levels to facilitate trade and to protect the health of their consumers. Member States could also overwrite some EC levels with higher national levels to accommodate new uses in the Member State concerned.

Negotiations on how to harmonise the setting of maximum residue levels across Europe under 396/2005, which finally came into force in September 2008, were lengthy and fraught with difficulties, highlighting the complexity of such a regime.

UK CA proposals

Therefore, the UK CAadvocatesthe development of a risk-based and proportional system for biocides for which implementation can occur progressively – i.e. tackling first the active substances of greatest concern to human health. This is preferable to rolling out a system for the establishment of maximum residue levels encompassing all active substances which may result as residues in food and feed. Such an all-encompassing system is likely to make very significant resource demands on both Member States and industry.

To support this approach, the UK CA is looking to coordinate or support industry in carrying out a scoping study to investigate use patterns of biocidal products in the food/feed manufacturing and catering industries, how and why these vary across different Member States and research into the levels of transfer of biocidal active substances into food/feed. In our view, we should await this information before decisions on the appropriate regulatory approach are taken. This approach has strong support from industry in the UK, including in particular the British Retail Consortium (BRC), the Chilled Food Association and the Food and Drink Federation (FDF).

A significant level of monitoring is already being undertaken by UK industry for DDAC and BAC and to identify suitable alternative cleaning agents. The Fresh Produce Consortium will coordinate the collation of industry monitoring data on chlorate residues to share with the UK CA and the Commission, and is liaising with the BRC on a pragmatic approach to retail monitoring programmes.

Equipped with a solid body of evidence based on this research, the Commission and Member States would be much better placed to formulate a proportionate approach.

Article 47 of Regulation (EC) 396/2005 requires it to be reviewed in 2015. Having outlined the problems with the setting of MRLs for ‘dual use’ active substances under 396/2005 we urge the Commission as part of the review to amend the Regulation so that the 0.01 mg/kg default LOD is not applied to the specific active substances with a biocidal use which fall under 396/2005. It would then be possible to undertake an EU harmonised review and set limits in other legislation.

Issues highlighted by UK industry

Parts of the chemical industry which supply biocidal products to the food/feed manufacturing and food retail/food service industries in relation to this default approach have raised many concerns.

For example, industry has argued that:

  • a default level at 0.01mg/kg will be hard to meet in practice. It is an arbitrarylow leveland exceeding it may not pose any dietary risk concerns (i.e. not risk based);
  • it does not reflect the need for food/feed to be protected from microbiological contamination or balance this against the need to reduce residues of biocidal actives in food/feed;
  • it may lead to a reduction in the number of disinfectant-type products available on the market, which will impact the ability of industry, and consequently FSA and DEFRA (and other Member States), to deal with any serious microbiological outbreaks;
  • the different treatment of single, dual and triple use biocides creates an uneven playing field leading to some biocides being penalised in the market by regulatory pressures irrespective of their safety profile. Thus, it should be a goal of this work to ensure that all active substances used for disinfection are treated equally, irrespective of whether they are also listed under veterinary medicines or PPP legislation; and
  • it may act as a barrier to international trade because the EU would be the first trading bloc to implement and enforce maximum residue limits/level for biocides.

Industry has suggested that setting maximum residue limits on a case-by-case basis using a tiered risk assessment approach would be more proportionate.[10] The UK CA could support this position and, if based on food safety, the limits would be established under Regulation 315/93.[11]

1

[1] Discussions on the Commission working document titled ‘Establishment of maximum residue levels for residues of active substances contained in biocidal products’, CA-Dec13-Doc.5.1.e

[2] See ‘Cefic and A.I.S.E. Plenary Discussion comments during the European Conference on MRL-Setting for Biocides in Berlin from March 18th to 19th 2014’ dated 26 March 2014.

[3] Regulation (EC) No. 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC

[4] A Good Agricultural Practice (GAP) is the nationally authorised safe uses of pesticides under conditions necessary for effective and reliable pest control (the way products should be used according to the statutory conditions of approval which are stated on the label). GAP encompasses a range of pesticide applications up to the highest authorised rates of use, applied in a manner which leaves a residue which is the smallest practicable. Authorised safe uses are determined at the national level and include nationally registered recommended uses, which take into account public and occupational health and environmental safety considerations. Actual conditions include any stage in the production, storage, transport, distribution and processing of food commodities and animal feed.

[5]Acceptable Daily Intake (ADI) is an estimate of the amount of substances in food expressed on a bodyweight basis that can be ingested daily over a lifetime, without appreciable risk to any consumer based on all known facts at the time of evaluation, taking into account sensitive groups within the population (e.g. children and the unborn).

[6]Acute Reference Dose (ARfD) is an estimate of the amount of substance in food, expressed on a body weight basis, that can be ingested over a short period of time, usually during one day, without appreciable risk to the consumer on the basis of the data produced by appropriate studies and taking into account sensitive groups within the population (e.g. children and the unborn).

[7]Council Regulation (EEC) No.2377/90 on laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.

[8]Limit of determination (LOD) means the validated lowest residue concentration that can be quantified and reported by routine monitoring with validated control methods.

[9] A decision voted on at the EU Standing Committee on The Food Chain and Animal Health (Residues) in June 2014.

[10] For further informationsee paper ‘Cefic and A.I.S.E. Plenary Discussion comments during the European Conference on MRL-Setting for Biocides in Berlin from March 18th to 19th 2014’, 24.03.2014 – available on request.

[11] Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food.