DIRECTORATE-GENERAL
ENVIRONMENT
Directorate B - Protecting the Natural Environment
ENV.B.3 - Biotechnology, Pesticides and Health
34th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market
Establishment of maximum residue levels for residues of active substances contained in biocidal products
Introduction
1)Article 10(2)ii(b) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market[1] lays down that, where relevant, maximum residue levels (MRLs) should be established.
2)However, unlike other legal frameworks, such as those for both veterinary medicinal products and plant protection products, no other specific Community legal instrument was developed detailing the rules for the establishment ofMRLs for active substances used as biocides.
3)In addition, residues of biocidal products that could be presentin food and feed do respond to the definition of contaminants, as provided under Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food[2].
4)This Regulation defines a 'contaminant' as any substance not intentionally added to food which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food, or as a result of environmental contamination.
5)Regulation (EEC) No 315/93 also provides that, where necessary, in order to protect public health, maximum tolerances for specific contaminants shall be established, except for contaminants subject of more specific Community rules, such as substances used in pesticides or veterinary medicinal products.
6)Against that complex legal background, it is however expected that, among the 270 existing substances remaining to be evaluated in the framework of the 10-year review programme under the Biocides Directive, as well as for new active substances, very few are likely to leave residues in food or feed under normal conditions of uses.
7)It is in addition expected that these substances will be used in products belonging to the following categories of product-type (PT), as listed in Annex V of the Directive:
PT3: Veterinary hygiene biocidal products
PT4: Food and feed area disinfectants
PT5: Drinking water disinfectants
PT18: Insecticides
PT19: Repellents
PT20: Preservatives for food and feedstocks[3]
General principles of food law
8)Regulation (EC) No 178/2002[4] laying down the general principles and requirements of food law establishes that food must not be placed on the market if it is unsafe, i.e. if it is harmful to health and/or unfit for consumption. In determining whether any food is unsafe, account is taken of the normal conditions of use, the information provided to the consumer, the likely immediate or delayed effect on health, the cumulative toxic effects and, where appropriate, the particular health sensitivities of a specific category of consumers.
9)In accordance with Article 14 of that Regulation, if food which is unsafe forms part of a batch, lot or consignment, the entire quantity is presumed to be unsafe.
10)Similarly, in accordance with Article 15 of that Regulation, feed must not be placed on the market or given to any food-producing animal if it is unsafe. Feed is deemed to be unsafe if it has an adverse effect on human or animal health. The entire quantity of a batch, lot or consignment is considered unsafe if any part of it fails to satisfy the requirements.
11)At all stages of the food production chain, business operators must ensure that food and feed satisfies the requirements of food law and that those requirements are being adhered to. The Member States enforce the law, ensuring that operators comply with it and laying down appropriate measures and penalties for infringements.
12)The traceability of food, feed, food-producing animals and all substances incorporated into foodstuffs must be established at all stages of production, processing and distribution. To this end, business operators are required to apply appropriate systems and procedures.
13)If an operator considers that a food or feed product which has been imported, produced, processed, manufactured or distributed is harmful to human or animal health, steps must be taken immediately to withdraw the product from the market and to inform the competent authorities accordingly. In cases where a product may have reached consumers, the operator must inform them and recall the products already supplied.
Recent developments
14)For substances used in biocidal products, Article 10(2)ii(b) of Directive 98/8/EC lays down that, where relevant, maximum residue levels (MRLs) should be established. However, unlike for veterinary medicinal products and plant protection products, no other specific Community legal instrument was developed detailing the rules for the establishment of MRLs for active substances used as biocides.
15)In the general context of better regulation and simplification, the Commission considered it unnecessary to develop a new piece of legislation, when the matter could be adequately addressed by existing legal instruments. Besides, if a separate legal framework had been developed for biocides, one would have run the risk of a substance ending up with different MRLs, as it already happened with substances used in both veterinary medicinal products and plant protection products.
16)The Commission therefore used the opportunity of the revision of Regulation 2377/90[5] to propose that the scope of the new regulation on the establishment of maximum residue limits for pharmacologically active substances in foodstuffs of animal origin also covers pharmacologically active substances containedin biocidal products used in animal husbandry.
17)The main rationale for applying a similar approach for residues of biocidal products and for those of veterinary medicinal products was twofold: first, from the control authorities point of view what matters is not so much the origin of the residue asits level; second, from the scientific point of view, the methodology to be followed is expected to be broadly similar.
18)This has now been accepted and Article10 of Regulation EC No 470/2009, which replaces Regulation 2377/90, provides a mechanism for the setting up of MRLs for substances used in biocidal products in animal husbandry. This will cover products such as veterinary hygiene biocidal products (PT3), insecticides (PT18) and repellents (PT19).
19)Discussions have now started with the EMEA, which will be responsible for issuing scientific opinions on MRLs for pharmacologically active substances used or intended to be usedin biocidal products used in animal husbandry. The details of the process and responsibilities will be established in co-operation between the Commission, the EMEA and a working group representing the MS Competent Authorities for biocides.
20)The Commission will now take the necessary steps to clarify the process for the establishment of MRLs for substances which may lead to the presence of residues inother circumstances than their use in animal husbandry. This process is expected to rely on Regulation 396/2005 and on the scientific input of EFSA.
21)Lastly, in the context of the revision of Directive 98/8/EC, the Commission has proposed a new wording to Article 10(2)ii(b), stating that where appropriate, maximum residue limits shall be established, with respect to active substances included in Annex I, in accordance with Regulation 396/2005 or Regulation 470/2009.
Maximum residue limits (MRLs)
22)Pursuant to Article 3(c) of Regulation396/2005, the maximum limits set by that Regulation apply toresidues of active substances which may arise as a result of use as a biocide, provided that the active substance is currently or formerly used in plant protection products.
23)Pursuant to Article(1)(1)(a) of Regulation470/2009, the maximum limits established pursuant to that Regulation apply to pharmacologically active substance, regardless of the use from which the residue results.
24)If specific MRLs have been established under Regulations 396/2005[6]or470/2009, then these arealready today applicable to residues of substances used in biocidal products.
25)If no specific MRLs have been established, then the default value of 0,01 mg/kg set out in Regulation 396/2005isapplicablefor residues of substances, which are also currently or were used in plant protection products[7].
26)The MRLs set under Regulation 396/2005apply to a wide range of commodities (see Annex II) as well as to processed products (e.g. oil, wine, juices, etc) or composite products (e.g. pizzas, ketchup, corn flakes, etc).
27)The residues of 83 of the 145 substances included in the review programme for PT 3, 4, 5, 18, 19 and 20 are thus already covered by specific or default MRLs, since they either have MRLs established under Regulation396/2005, are currently or formerly used in plant protection products, or have MRLs laid down in one of the annexes to Regulation2377/90, which are still applicable pursuant to Article29 of Regulation470/2009 (see Annex I to this note for details).
28)However, among the 62 remaining substances, not all of them will be used in a context, where they might lead to the presence of residues.
29)If they lead to the presence of residues and if it is necessary to establish MRLs, this would be done, depending on the area of use, via Regulation 396/2005 or Regulation 470/2009. For Regulation 396/2005, it would however require an amendment of the current text to enlarge its scope to residues of substances used in biocidal products only.
30)Also, for MRLs of active substances currently or formerly used for plant protection, the applicant/authorisation holder could where necessary apply for the establishment of MRLs, less penalising than the default value of 0,01 mg/kg. This would however also require the same amendment of Regulation 396/2005 as indicated above.
31)Lastly, if residues are found in food or feed and that no MRLs, either specific or default, have been established, then Articles 14 and 15 of the General Food Law would apply and the food or the feed could be declared unsafe after an ad hoc risk assessment.
32)In specific cases, the Commission services could also rely on the provisions of Regulation (EEC) No 315/93 on contaminants and set up specific limits for the residues of certain substances.
33)Commission Regulation (EC) 1881/2006[8]already sets limits for:
- mycotoxins (aflatoxins, ochratoxin A, patulin, deoxynivalenol, zearalenone, fumonisins, T2 and HT-2-toxin)
- metals (cadmium, lead, mercury and inorganic tin)
- dioxins and dioxin-like PCBs
- 3-MCPD
- polycyclic aromatic hydrocarbons (benz(o)pyrene).
Authorisation of biocidal products
34)For products containing active substances that may lead to residues in food or feed, Member States shall ensure that products are only authorised if these residues have no unacceptable effects on human health, in accordance with Article 5(1)(b)(iii) of Directive98/8/EC.
35)Competent Authorities for Biocidal Products, when granting authorisations for products that may leave residues into food or feed would however not be expected to set MRLs but should ensure that the directions for use of the product contain inter aliaappropriate directions to prevent animals or plants from being unnecessarily exposed to the active substance or to relevant degradation products (e.g. 'Do not use in the presence of the animals', 'Animals shall not re-enter the room before 24 hours after the end of the application of the product') or to remove food before treatment (e.g. 'Do not use in the presence of food commodities'). Other measures might be added to ensure that the level of residues tolerated in food shall not be exceeded.
36)These measures will be derived from the risk assessment and will take into account the conditions of use of the product.
37)Applicants will thereforeneed to submit residues data to allow competent authorities to perform this risk assessment. However, as it can realistically not be expected that residue data will be available for each and every food commodity, the absence of an exhaustive data set could be compensated by taking a conservative approach in the risk assessment.
38)Finally, Annex I inclusions for substances that may lead to the presence of residues in food will contain a specific provision stating that:
39)For products containing substance X that may lead to residues in food, Member States shall ensure that labels and/or safety data sheets must contain instructions for use, such as the adherence to waiting periods,which ensure that MRLs set out in Regulation (EC) No 396/2005 of the European Parliament and of the Council(*) or, as appropriate, established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (**) are not exceeded.
Enforcement and controls
40)Food business operators are responsible for food safety, which includes compliance with MRLs. Member State authorities are responsible for control and enforcement of the MRLs. To ensure that this is done in an adequate and uniform way, the Commission relies on several instruments:
41)In the veterinary sector, Council Directive 96/23/EC[9] on measures to monitor certain substances and residues thereof in live animals and animal products establishes that Member States should draft a national residue monitoring plan for the groups of substances detailed in Annex I. These plans must comply with the sampling rules in Annex IV to the Directive.
42)Directive 96/23/EC establishes the frequencies and level of sampling and the groups of substances to be controlled for each food commodity. Commission Decision 97/747/EC[10] provides further rules for certain animal products: milk, eggs, honey, rabbits and game meat. Commission Decision 98/179/EC[11] of 23 February 1998 lays down detailed rules for official sampling procedures and official treatment of samples until they reach the laboratory responsible for analysis.
43)In the plant protection sector, the co-ordinated EU multi-annual control programme[12]established by Regulation (EC) No 396/2005 sets out for each MemberState the main pesticide-crop combinations to monitor and the minimum numbers of samples to take. Member States have to report the results, which are published in an annual report.
44)Community Reference Laboratories[13] co-ordinate, train staff, develop methods of analysis and organise tests to evaluate the skills of the different national control laboratories.
45)The Food and Veterinary Office[14] of the Commission carries out inspections in the Member States to assess and audit their control activities.
46)If residues of pesticides or of veterinary medicinal products are found at a level of concern for consumers, the Rapid Alert System for Food and Feed[15](RASFF) circulates the information and measures are taken to protect the consumer
47) In any event, control authorities when monitoring the presence of residues would refer themselves to Regulations 396/2005 and 470/2009.
Annex I
Substances included in the review programme for PT 3, 4, 5,19 or 20
common name / 3 / 4 / 5 / 18 / 19 / 20 / PPP MRL / VMP MRL / Current or Former PPP2-Butanone, peroxide / x
2-chloroacetamide / x
2-Phenoxyethanol / x / x
Abamectin / x / x / Annex I / x
Acetamiprid / x / x / x
Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ / x / x / x
ADBAC / x / x / x / x
ADBAS / x / x / x
Akacid / x / x / x / x
Akacid forte / x / x / x / x
alpha-Cypermethrin / x / x / Annex I / x
Aluminium Phosphide / x / x / x / x
Ampholyt 20 / x / x
Azamethiphos / x / x / Annex I, II, III / x
Bacillus sphaericus strain 2362 / x / x / x
Bacillus subtilis / x / x / x
Bardap 26 / x
Bendiocarb / x / x / x
Benzoic acid / x / x / x / Annex II (E210) / x
Biphenyl-2-ol / x / x
BKC / x / x / x / Annex II / x
Bromoacetic acid / x
BTI strain AM65-52 / x / x / x
BTI strain SA3A / x / x / x
Calcium dihydroxide / calcium hydroxide / caustic lime / hydrated lime / slaked lime / x / x / Annex II / x
Calcium hypochlorite / x / x / x
Calcium magnesium oxide / dolomitic lime / x
Calcium magnesium tetrahydroxide / calcium magnesium hydroxide / hydrated dolomitic lime / x
Calcium oxide / lime / burnt lime / quicklime / x / x / Annex II / x
Carbon dioxide / x / x / x / Annex II (E290) / x
CHDG / x
Chlorfenapyr / x / x / x
Chlorine / x
Chlorine dioxide / x / x / x
Chlorocresol / x / Annex II
Chlorophene / x
Chrysanthemum cinerariaefolium, ext. / x / Annex II
Cis-tricos-9-ene / x
Citriodiol / x
Clothianidin / x / x / x
Copper / x / x
Copper sulphate / x / x
Cyanamide / x / x / x / x
Cyclopropanecarboxylic acid, 3-[(xZ)-2-chloro-3,3,3-trifluoro-x-propenyl]-2,2-dimethyl-, (2-methyl[x,x’-biphenyl]-3-ylmethyl ester, (xR,3R)-rel- / Bifenthrin / Biphenate / x / x
Cyfluthrin / x / x / Annex I / x
Cypermethrin / x / x / Annex I / x
Cyphenothrin / x
Cyromazine / x / x / Annex I / x
d-Allethrin / x / x
DBNPA / x
DCPP / x
DDAC / 2 / 2 / x / x
Decanoic acid / x / x / x / x
DEET / x / x / x
Deltamethrin / x / x / Annex I / x
Diamine / x / x
Dichlorvos / x / x / x
Diflubenzuron / x / x / Annex I / x
Disodium peroxodisulphate / Sodium persulphate / x
d-Phenothrin / x / x
d-Tetramethrin / x
Empenthrin / x
Esbiothrin / x / x
Esfenvalerate / x / x / x
Ethanol / x / x / Annex II / x
Etofenprox / x / x / x
Fipronil / x / x / x
Flufenoxuron / x / x / x
Formaldehyde / x / x / x / x / Annex II / x
Formic acid / x / x / x / x / Annex II / x
Geraniol / x / x
Glucoprotamin / x
Glutaraldehyde / x / x / x / Annex II
Glycollic acid / x / x
Glyoxal / x / x / x
Hexaflumuron / x / x / x
Hydrogen cyanide / x / x
Hydrogen peroxide / x / x / x / x / Annex II / x
Icaridine / x
Imazalil / x / x / x
Imidacloprid / x / x / x
Imiprothrin / x
Iodine / x / Annex II
IR3535 / x
L-(+)-lactic acid / x / x / x / Annex II / x
Lambda cyhalothrin / x / x / x
Lauric acid / x / x
Lavender, Lavandula hybrida, ext. / Lavandin oil / x
Magnesium Phosphide / x / x / x / x
Margosa extract / x / x
Methylneodecanamide / MNDA22 / x
Methynonylketone / x / x
Mixture of CMIT/MIT / x
Naled / x / x / x
Nitrogen / x / x / x
Nonanoic acid / x
Octanoic acid / x / x / x
PAP / x / x
Pentapotassium bis(peroxymonosulphate) bis(sulphate) / x / x / x
Peracetic acid / x / x / x / x / Annex I / x
Perestane / x
Permethrin / x / x / Annex I / x
Peroxyoctanoic acid / x / x
PHMB / x / x / x
Piperonyl butoxide / PBO / x / x / Annex II / x
Poly(hexamethylenebiguanide) / x / x
Polymer of formaldehyde and acrolein / x
Prallethrin / x
Propan-1-ol / x
Propan-2-ol / x
PVP-iodine (see iodine) / x / Annex II
Pyrethrins and Pyrethroids / x / x / x / x
Pyriproxyfen / x / x / x
Quaternary ammonium compounds, benzyl-Cx2-x4-alkyldimethyl, chlorides (see ADBAC) / x / x / x / x
Quaternary ammonium compounds, benzyl-Cx2-x8-alkyldimethyl, chlorides (see ADBAC) / x / x / x / x
Quaternary ammonium compounds, Cx2-x4-alkyl[(ethylphenyl)methyl]dimethyl, chlorides (see ADBAC) / x / x / x / x
Quaternary ammonium compounds, di-C8-x0-alkyldimethyl, chlorides (see DDAC) / x / x / x / x / x
Salicylic acid / x / x / x
Silicium dioxide / Kieselguhr / x / Annex II (E551) / x
Silicon dioxide – amorphous / x / x / Annex II (E552)
Silver / x / x
Silver chloride / x / x / x
Silver sodium hydrogen zirconium phosphate / x
Silver zeolite A / x / x
S-Methoprene / x / x / x
Sodium 2-biphenylate / x / x
Sodium Cacodylate / x / x / x
Sodium dichloroisocyanurate dihydrate / x / x / x / Annex II
Sodium hypochlorite / x / x / x / x / x
Sodium p-chloro-m-cresolate / x
Sodium pyrithione / x
Spinosad / x / x / x
Sulfuryl fluoride / x / x / x
Sulphur dioxide / x / x / x
Symclosene / x / x / x
TCDO / x / x
Technical grade imazalil / x / x / x
Tetramethrin / x / x / x
Thiamethoxam / x / x / x
Tosylchloramide sodium - Chloramin T / x / x / x
Transfluthrin / x
Triclosan / x
Triflumuron / x / x / x
Troclosene sodium / x / x / x
ZE-TDA / x
AnnexII
List of commodities for which MRLs are established under Regulation 396/2005
x / 0x00000 / x. FRUIT FRESH OR FROZEN; NUTS2 / 0xx0000 / (i) Citrus fruit
4 / 0xx00x0 / Grapefruit (Shaddocks, pomelos, sweeties, tangelo, ugli and other hybrids)
4 / 0xx0020 / Oranges (Bergamot, bitter orange, chinotto and other hybrids)
4 / 0xx0030 / Lemons (Citron, lemon )
4 / 0xx0040 / Limes
4 / 0xx0050 / Mandarins (Clementine, tangerine and other hybrids)
4 / 0xx0990 / Others
2 / 0x20000 / (ii) Tree nuts (shelled or unshelled)
4 / 0x200x0 / Almonds
4 / 0x20020 / Brazil nuts
4 / 0x20030 / Cashew nuts
4 / 0x20040 / Chestnuts
4 / 0x20050 / Coconuts
4 / 0x20060 / Hazelnuts (Filbert)
4 / 0x20070 / Macadamia
4 / 0x20080 / Pecans
4 / 0x20090 / Pine nuts
4 / 0x20x00 / Pistachios
4 / 0x20xx0 / Walnuts
4 / 0x20990 / Others
2 / 0x30000 / (iii) Pome fruit
4 / 0x300x0 / Apples (Crab apple)
4 / 0x30020 / Pears (Oriental pear)
4 / 0x30030 / Quinces
4 / 0x30040 / Medlar
4 / 0x30050 / Loquat
4 / 0x30990 / Others
2 / 0x40000 / (iv) Stone fruit
4 / 0x400x0 / Apricots
4 / 0x40020 / Cherries (sweet cherries, sour cherries)
4 / 0x40030 / Peaches (Nectarines and similar hybrids)