Tag Archives: Marketing standard

Marketing of feed

Marketing of feed

Outline of the Community (European Union) legislation about Marketing of feed

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Marketing of feed

Document or Iniciative

Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC.

Summary

This Regulation lays down rules on the placing on the market and use of feed for food-producing animals or pets. It also lays down labelling, packaging and presentation requirements.

Feed

This Regulation covers feed, i.e. any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals.

It applies without prejudice to provisions in the field of animal nutrition concerning:

  • medicated feedingstuffs;
  • undesirable substances;
  • transmissible spongiform encephalopathies;
  • animal by-products not intended for human consumption;
  • genetically modified food and feed;
  • the traceability and labelling of genetically modified organisms (GMOs);
  • additives; and
  • the production and labelling of organic products.

Marketing and use

Animal feed shall comply with safety and marketing requirements. In particular, it shall:

  • be safe;
  • not have a direct adverse effect on the environment or animal welfare;
  • be sound, genuine, unadulterated, fit for purpose and of merchantable quality;
  • be labelled, packaged and presented in accordance with the applicable legislation; and
  • comply with the technical provisions on impurities and other chemical determinants (see Annex I to the Regulation).

Feed shall not contain materials whose placing on the market or use is restricted or prohibited (see Annex III to the Regulation).

The traceability of feed shall be guaranteed at all stages of production, processing and distribution. Feed business operators must therefore be capable of identifying any person who has provided them with feed, a food-producing animal or any substance intended or likely to be incorporated into feed.

Feed which is or is likely to be placed on the market in the European Community shall be labelled or identified appropriately in order to facilitate its traceability.

If the feed business operator considers that a feed does not meet the feed safety requirements, it shall immediately initiate the procedures for withdrawing the feed in question from the market. It shall then inform the competent authorities and users without delay.

Labelling and presentation

This Regulation establishes general provisions for the labelling and presentation of all feed, such as the obligation to indicate:

  • the type of feed;
  • the name and address of the operator;
  • the batch or lot reference number;
  • the net weight;
  • the list of additives used; and
  • the moisture content.

The labelling and presentation of feed must not mislead the user concerning the intended use or characteristics of the feed. The mandatory labelling particulars shall be clearly visible on the packaging, the container, on a label attached thereto or on the document accompanying the feed. The particulars shall be clearly legible and indelible. They shall be given in at least one of the official languages of the Member State or region in which the feed is marketed.

Specific labelling requirements are laid down for feed materials, compound feed and “dietetic” feed. All claims relating to feed must be duly justified.

The labelling of pet food shall include a telephone number for customers wishing to know more about the ingredients used.

Packaging

Feed materials and compound feed shall be placed on the market in sealed packages and containers.

However, certain feed may be placed on the market in bulk or in unsealed packages or containers. This derogation concerns:

  • feed materials;
  • mixtures of grain and whole fruit;
  • deliveries between producers of compound feed;
  • compound feed delivered by the producer to the user or packaging firms;
  • quantities of compound feed not exceeding 50 kilograms in weight which are intended for the final user and are taken directly from a sealed package or container; and
  • blocks or licks.

Community Catalogue of feed materials

The Community Catalogue of feed materials is intended to improve the labelling of feed materials and compound feed. For each material listed, it includes the following particulars:

  • the name;
  • the identification number;
  • a description (including information on the manufacturing process); and
  • a glossary of definitions.

Community Codes of good labelling practice

Stakeholders are also encouraged to create Community Codes of exemplary practice in the context of optional labelling: one for pet food and one for compound feed for food-producing animals.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 767/2009

21.9.2009

OJ L 229 of 1.9.2009

Subsequent amendments and corrections to Regulation (EC) No 767/2009 have been incorporated in the basic text. This consolidated versionhas a purely documentary value”.

DEROGATION FROM THE ACT

Regulation (EU) No 454/2010 [Official Journal L 128 du 27.5.2010].
Feed intended for pet animals which is labelled in accordance with Directive 79/373/EEC and Article 16 of Directive 70/524/EEC may be placed on the market until 31 August 2011.

Related Acts

Commission Regulation (EU) No 242/2010 of 19 March 2010 creating the Catalogue of feed materials [Official Journal L 77 of 24.3.2010].

Passenger restraint devices on two-wheel vehicles

Passenger restraint devices on two-wheel vehicles

Outline of the Community (European Union) legislation about Passenger restraint devices on two-wheel vehicles

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Motor vehicles > Technical implications of road safety

Passenger restraint devices on two-wheel vehicles

Document or Iniciative

Directive 2009/79/EC of the European Parliament and of the Council of 13 July 2009 on passenger hand-holds on two-wheel motor vehicles (Codified version) (Text with EEA relevance).

Summary

This Directive sets out requirements for passenger hand-holds for all types of two-wheel motor vehicles in Category L.

Types of vehicle concerned by the Directive

This Directive shall apply to:

  • mopeds: two-wheel vehicles (Category L1e) with a maximum design speed not exceeding 45 km/h;
  • motorcycles: two-wheel vehicles without sidecars (Category L3e) or with sidecars (Category L4e), with a cylinder capacity exceeding 50 cm3, for internal combustion engines, and/or the maximum design speed of which exceeds 45 km/h.

General prescriptions for passenger hand-holds

Two-wheel vehicles must be equipped with a passenger hand-hold system, composed of a strap or one or more hand-grips.

The strap must be fitted to the seat of the vehicle so that it may easily be used by the passenger. The strap and its attachment must withstand a vertical traction force of 2000 N with a maximum pressure of 2 MPa.

The hand-grip must be close to the saddle. Like the strap, it must withstand a vertical traction force of 2000 N with a maximum pressure of 2 MPa. If two handgrips are used, they must be fitted symmetrically.

Procedure for the granting of EC component type-approval

The manufacturer of the vehicle makes an application for EC type-approval to the type-approval authority of the Member State, using an information document.

The certificate of conformity is issued by the competent authority, which has a period of one month to inform the competent authorities of Member States.

In the event of non-compliance with the requirements of this Directive, Member States may refuse EC type-approval for any two-wheel motor vehicle for reasons relating to the passenger restraint device.

Context

This Directive repeals Directive 93/32/EC.

REFERENCES

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2009/79/EC

21.8.2009

OJ L 201 of 1.8.09

Unique identifiers for GMOs

Unique identifiers for GMOs

Outline of the Community (European Union) legislation about Unique identifiers for GMOs

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Specific themes

Unique identifiers for GMOs

Document or Iniciative

Commission Regulation (EC) No 65/2004 of 14 January 2004, establishing a system for the development and assignment of unique identifiers for genetically modified organisms.

Summary

Scope

The Regulation applies to all genetically modified organisms that will be imported into the Community for cultivation and for human food and animal feed, except medicinal products for human and veterinary use.

Authorisation to place on the market

Since the beginning of the 1990s, the placing on the market of genetically modified organisms has been regulated by Directive 90/220/EEC. Since 1997, the regulations on GMOs, limited to Directive 90/220/EEC (covering the import, processing and cultivation of GMOs and their use in animal feed) have been strengthened by a Regulation concerning novel foods and novel food ingredients intended for human food (Regulation 97/258/EC).

The regulatory framework for GMOs was amended and updated by the adoption of Directive 2001/18/EC repealing the above-mentioned Directive 90/220/EEC, and by the adoption of two Regulations, one relating to GMOs in human food and animal feed (Regulation 1829/2003/EC) and the other to the labelling and traceability of GMOs (Regulation 1830/2003/EC).

All GMOs must be assessed before they can be sown or placed on the market. This risk assessment is carried out on a case-by-case basis and examines the expected or unexpected possible effects that the GMO is likely to have on health and on the environment. Therefore, effects linked to a GMO’s potential toxicity/allergenicity or its effects on non-target organisms for example are evaluated by national and Community scientific bodies (including the European Food Safety Authority).

Once GMO products have been authorised to be placed on the market (Directive 2001/18/EC or Regulation 1829/2003), the appropriate identifier unique to each GMO must be included on the labelling.

The identifier is made up of 9 characters, including letters and numbers, combined in a uniform way (see the Regulation’s annex). This format was approved within the framework of the Organisation for Economic Cooperation and Development (OECD). The identifier for each specific GMO is therefore listed in the OECD’s BioTrack database.

The Commission or the authority that approved the product’s marketing must inform the Biosafety Clearing-House (set up under the Cartagena Biosafety Protocol) in writing of this unique identifier.

Context

The unique identifier is a GMO identification measure that is also linked to labelling and which facilitates the traceability of these products throughout the food chain, in application of Regulation 1830/2003.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 65/2004 16/01/2004 OJ L 10 of 16/01/2004

Related Acts

Regulation (EC) No 641/2004 of the Commission of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (Official Journal L 102 of 07/04/2004).


Regulation (EC) No 1830

of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (Official Journal L 268 of 18/10/2003).

 

Road safety: transportable pressure equipment

Road safety: transportable pressure equipment

Outline of the Community (European Union) legislation about Road safety: transportable pressure equipment

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Transport > Road transport

Road safety: transportable pressure equipment

Document or Iniciative

Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC.

Summary

This directive updates certain technical provisions of Directive 1999/36/EC to avoid conflicting rules. It sets out detailed rules on transportable pressure equipment *to improve safety and to ensure free movement of such equipment within the European Union (EU).

This directive applies to:

  • new transportable pressure equipment which does not bear the conformity markings provided for in Directives 84/525/EEC, 84/526/EEC, 84/527/EEC or 1999/36/EC, for the purpose of making it available on the market;
  • transportable pressure equipment bearing the conformity markings provided for in the above directives, for the purposes of its periodic inspections, intermediate inspections, exceptional checks and use;
  • transportable pressure equipment which does not bear the conformity markings provided for in Directive 1999/36/EC, for the purposes of reassessment of conformity.

This directive does not apply to:

  • transportable pressure equipment placed on the market before the implementation date of Directive 1999/36/EC and which has not been subject to a reassessment of conformity;
  • transportable pressure equipment exclusively used for the transport of dangerous goods between EU and non-EU countries, undertaken in accordance with Directive 2008/68/EC.

Obligations of economic operators *

Manufacturers must ensure that when placing their transportable pressure equipment on the market, the equipment has been designed, manufactured and documented in compliance with the requirements in both this directive and in Directive 2008/68/EC. When this compliance is demonstrated through the conformity assessment process, manufacturers must affix the Pi marking * to the equipment. This Pi marking must only be affixed by the manufacturer or, in cases of reassessment of conformity, by or under the surveillance of the notified body.

If manufacturers believe that they have placed on the market transportable pressure equipment that does not conform to the requirements, they must immediately take the necessary corrective measures to fulfil the requirements and, where appropriate, withdraw or recall the equipment from the market. If requested by the competent national authority, manufacturers must provide all documents to prove the conformity of their equipment, in a language easily understood by the authority.

Manufacturers may, by a written mandate, appoint an authorised representative. The mandate will specify tasks for the authorised representative to undertake, but will include:

  • keep the technical documentation at the disposal of national surveillance authorities;
  • provide the competent national authority, on request, with all necessary information and documentation to prove the conformity of the transportable pressure equipment;
  • cooperate with the competent national authorities on action taken to eliminate any risks posed by the equipment covered by the mandate.

Importers and distributors may only place on the EU market transportable pressure equipment that complies with Directive 2008/68/EC and this directive. They must ensure that the equipment bears the Pi marking and has the necessary certificate of conformity. Where importers or distributors do not believe the equipment to be in conformity, they must not place it on the market.

Importers, distributors and owners must:

  • inform the manufacturer and competent authority of any risk presented by the equipment. Alternatively, where relevant, the distributor can inform the importer and the owner can inform either the distributor or the importer of such a risk;
  • document all instances of non-compliance and corrective measures;
  • ensure that when transportable pressure equipment is under their responsibility, storage or transport conditions do not jeopardise its conformity.

The above does not apply to private individuals intending to use the equipment for their personal use, leisure or sporting activities.

Conformity of transportable pressure equipment

The transportable pressure equipment must meet the relevant conformity assessment, periodic inspection, intermediate inspection and exceptional checks requirements, as well as the specifications of the documentation according to which the equipment was manufactured;

Free movement of transportable pressure equipment

No EU country may prohibit, restrict or impede the free movement, the placing on the market and the use of transportable pressure equipment on their territory, when the above complies with this directive.

Key terms used in the act
  • Transportable pressure equipment:
    • all pressure receptacles, their valves and other accessories when appropriate;
    • tanks, battery vehicles / wagons, multiple-element gas containers (MEGCs), their valves and other accessories when appropriate;
    • includes gas cartridges but excludes aerosols, open cryogenic receptacles, gas cylinders for breathing apparatus and fire extinguishers;
  • economic operator: the manufacturer, the authorised representative, the importer, the distributor, the owner or the operator acting in the course of a commercial or public service activity, whether in return for payment or free of charge;
  • Pi marking: marking which indicates that the transportable pressure equipment is in conformity with the applicable conformity assessment requirements set out in Directive 2008/68/EC and in this directive.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2010/35/EU

20.7.2010

30.6.2011

OJ L 165 of 30.6.2010

The placing of plant protection products on the market

The placing of plant protection products on the market

Outline of the Community (European Union) legislation about The placing of plant protection products on the market

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Plant health checks

The placing of plant protection products on the market (until June 2011)

The European Union has harmonised the conditions and procedures for authorising plant protection products so as to protect human health and the environment. It has also drawn up a list of authorised substances and a phased programme for evaluating substances already on the market.

Document or Iniciative

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [See Amending Acts].

Summary

The Directive lays down uniform rules on the evaluation, authorisation, placing on the market and control within the European Union of plant protection products * and the active substances * they contain.

Only plant protection products whose active substances are listed in Annex I to the Directive and that do not pose a risk to human or animal health or the environment when the product is used under normal conditions are authorised.

The procedure for evaluating and authorising plant protection products must comply with the uniform principles laid down in Annex VI to the Directive. These include:

  • general principles: the evaluation of data in the light of current knowledge, taking account of the particular conditions prevailing in the zone in which the product is to be used, etc;
  • specific principles concerning, among other things, efficacy, the absence of unacceptable effects on plants, the impact on human and animal health and on non-target species, distribution in and impact on the environment, etc.

The Directive stipulates the requirements for the dossier to be submitted for the inclusion of an active substance in the list of authorised substances (Annex II) and the requirements for the dossier to be submitted for the authorisation of a plant protection product (Annex III). These requirements concern, among other things, the identification of the substance or product, the identity of the manufacturer and applicant for authorisation, tests and analyses carried out by official or officially-recognized testing facilities or organisations, etc. Information held by the applicant or manufacturer may be protected by a confidentiality clause where it constitutes an industrial or commercial secret.

Authorisation is granted by the Member State on whose territory the product is placed on the market for the first time. It is valid for ten years and may be renewed. It can be withdrawn if the requirements are no longer fulfilled and can be amended if the development of scientific and technical knowledge requires.

To ensure the free circulation of products, the Directive provides for mutual recognition of authorisations granted by the Member States, provided that the plant health, agricultural and environmental conditions are comparable in the regions concerned. It does, however, contain a protective clause permitting Member States temporarily to restrict or prohibit the circulation of a product on their territory if it poses a risk to human or animal health or to the environment.

Every quarter, the Member States inform the Commission and the other Member States of all plant protection products authorised or withdrawn. In addition, every year Member States draw up and send to the Commission and the other Member States a list of products authorised on their territory.

Arrangements for provisional authorisation allow Member States, pending the Community’s decision to include a new active substance in the positive list, to authorise the plant protection product concerned for a maximum of three years if the dossier submitted for inclusion of the active substance and the dossier for the authorisation of the plant protection product are in order and if it is established that the active substance and the product pose no risk.

As regards active substances currently on the market, the Directive provides for an evaluation programme for these substances over a period of 12 years from the entry into force of the Directive. This programme was extended until March 2009. Since the end of 2003, the European Food Safety Authority has been responsible for assessing risks, while the Commission is still responsible for taking decisions concerning risk management.

The Directive also harmonises the rules on the labelling and packaging of plant protection products and the information they must bear, among other things, the name and designation of the product, the name and address of the holder of the authorisation, the quantity of each active substance, the directions for use, the dose for each authorised use and particulars of possible phytotoxicity, etc.

Context

This Directive is repealed with effect from 14 June 2011 by Regulation (EC) No 1107/2009 on the placing on the market of plant protection products.

Key terms used in the act
  • Plant protection products: these are products consisting of, or containing, active substances, safeners or synergists, intended for one of the following uses:
    • protecting plants or plant products against all harmful organisms or preventing the action of such organisms, except if they are mainly designed for reasons of hygiene rather than protection of vegetables or vegetable products;
    • influencing the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
    • preserving plant products, in so far as such substances or products are not subject to Community provisions on preservatives;
    • destroying undesirable plants, or parts thereof, with the exception of algae;
    • checking or preventing undesired growth of plants, except algae.
  • Active substances: substances or micro-organisms, including viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 91/414//EEC

26.7.1991 (notification)

26.7.1993

OJ L 230 of 19.8.1991

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 806/2003

5.6.2003

OJ L 122 of 16.5.2003

Regulation (EC) No 396/2005

5.4.2005

OJ L 70 of 16.3.2005

AMENDMENT OF ANNEXES

Annex I – Active substances authorised for use in plant protection products:

Directive 2000/80/EC (lambda-cyhalothrin) [Official Journal L 309 of 9.12.2000];
Directive 2001/21/EC (amitrole, diquat, pyridate and thiabendazole) [Official Journal L 69 of 10.3.2001];
Directive 2001/28/EC (fenhexamid) [Official Journal L 113 of 24.4.2001];
Directive 2001/47/EC (paecilomyces fumosoroseus) [Official Journal L 175 of 28.6.2001];
Directive 2001/49/EC (flupyrsulfuron-methyl) [Official Journal L 176 of 29.6.2001];
Directive 2001/87/EC (acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl) [Official Journal L 276 of 19.10.2001];
Directive 2001/99/EC (glyphosate and thifensulfuron-methyl) [Official Journal L 304 of 21.11.2001];
Directive 2001/103/EC (2,4-dichlorophenoxy acetic acid) [Official Journal L 313 of 30.11.2001];
Directive 2002/18/EC (isoproturon) [Official Journal L 55 of 26.2.2002];
Directive 2002/37/EC (ethofumesate) [Official Journal L 117 of 4.5.2002];
Directive 2002/48/EC (iprovalicarb, prosulfuron and sulfosulfuron) [Official Journal L 148 of 6.6.2002];
Directive 2002/64/EC (cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M and picolinafen) [Official Journal L 189 of 18.7.2002];
Directive 2002/81/EC (flumioxazine) [Official Journal L 276 of 12.10.2002];
Directive 2003/5/EC (deltamethrin) [Official Journal L 8 of 14.1.2003];
Directive 2003/23/EC (imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid) [Official Journal L 81 of 28.3.2003];
Directive 2003/31/EC (2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin) [Official Journal L 101 of 23.4.2003];
Directive 2003/39/EC (propineb and propyzamide) [Official Journal L 124 of 20.5.2003];
Directive 2003/68/EC (trifloxystrobin, carfentrazone ethyl, mesotrione, fenamidone and isoxaflutole) [Official Journal L 177 of 16.7.2003];
Directive 2003/70/EC (mecoprop, mecoprop-P and propiconazole) [Official Journal L 184 of 23.7.2003];
Directive 2003/79/EC (coniothyrium minitans) [Official Journal L 205 of 14.8.2003];
Directive 2003/81/EC (molinate, thiram and ziram) [Official Journal L 224 of 6.9.2003];
Directive 2003/84/EC (flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam) [Official Journal L 247 of 30.9.2003];
Directive 2003/112/EC (paraquat) [Official Journal L 321 of 6.12.2003];
Directive 2003/119/EC (mesosulfuron, propoxycarbazone and zoxamide) [Official Journal L 325 of 12.12.2003];
Directive 2004/20/EC (chlorpropham) [Official Journal L 70 of 9.3.2004];
Directive 2004/30/EC (benzoic acid, flazasulfuron and pyraclostrobin) [Official Journal L 77 of 13.3.2004];
Directive 2004/58/EC (alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham) [Official Journal L 120 of 24.4.2004];
Directive 2004/60/EC (quinoxyfen) [Official Journal L 120 of 24.4.2004];
Directive 2004/62/EC (mepanipyrim) [Official Journal L 125 of 28.4.2004];
Directive 2004/71/EC (Pseudomonas chlororaphis) [Official Journal L 127 of 29.4.2004];
Directive 2004/99/EC (acetamiprid and thiacloprid [Official Journal L 309 of 6.10.2004];
Directive 2005/2/EC (Ampelomyces quisqualis and Gliocladium catenulatum) [Official Journal L 20 of 22.1.2005];
Directive 2005/3/EC (imazosulfuron, laminarin, methoxyfenozide and s-metolachlor) [Official Journal L 20 of 22.1.2005];
Directive 2005/34/EC (etoxazole and tepraloxydim) [Official Journal L 125 of 18.5.2005];
Directive 2005/53/EC (chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl) [Official Journal L 241 of 17.9.2005];
Directive 2005/54/EC (tribenuron) [Official Journal L 244 of 20.9.2005];
Directive 2005/57/EC (MCPA and MCPB) [Official Journal L 246 of 22.9.2005];
Directive 2005/58/EC (bifenazate and milbemectin) [Official Journal L 246 of 22.9.2005];
Directive 2005/72/EC (chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram) [Official Journal L 279 of 22.10.2005];
Directive 2006/5/EC (warfarin) [Official Journal L 12 of 18.1.2006];
Directive 2006/6/EC (tolylfluanid) [Official Journal L 12 of 18.1.2006];
Directive 2006/10/EC (forchlorfenuron and indoxacarb) [Official Journal L 25 of 28.1.2006];
Directive 2006/19/EC (1-methylcyclopropene) [Official Journal L 44 of 15.2.2006];
Directive 2006/39/EC (clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole) [Official Journal L 104 of 13.4.2006];
Directive 2006/41/EC (clothianidin and pethoxamid) [Official Journal L 187 of 8.7.2006];
Directive 2006/45/EC (propoxycarbazone) [Official Journal L 130 of 18.5.2006];
Directive 2006/64/EC (clopyralid, cyprodinil, fosetyl and trinexapac) [Official Journal L 206 of 27.7.2006];
Directive 2006/74/EC (dichlorprop-P, metconazole, pyrimethanil and triclopyr) [Official Journal L 235 of 30.8.2006];
Directive 2006/75/EC (dimoxystrobin) [Official Journal L 248 of 12.9.2006];
Directive 2006/85/EC (fenamiphos and ethephon) [Official Journal L 293 of 24.10.2006];
Directive 2006/131/EC (methamidophos) [Official Journal L 349 of 12.12.2006];
Directive 2006/132/EC (procymidone) [Official Journal L 349 of 12.12.2006];
Directive 2006/133/EC(flusilazole) [Official Journal L 349 of 12.12.2006];
Directive 2006/134/EC (fenarimol) [Official Journal L 349 of 12.12.2006];
Directive 2006/135/EC (carbendazim) [Official Journal L 349 of 12.12.2006];
Directive 2006/136/EC (dinocap) [Official Journal L 349 of 12.12.2006];
Directive 2007/5/EC (captan, folpet, formetanate and methiocarb) [Official Journal L 35 of 8.2.2007];
Directive 2007/6/EC (metrafenone, Bacillus subtilis , spinosad and thiamethoxam) [Official Journal L 43 of 15.2.2007];
Directive 2007/21/EC (azoxystrobin, imazalil, kresoxim-methyl, spiroxamin, azimsulfuron, prohexadion-calcium and fluroxypyr) [Official Journal L 97 of 12.4.2007];
Directive 2007/25/EC (dimethoate, dimethomorph, glufosinate, metribuzin, phosmet and propamocarb as active substances) [Official Journal L 106 of 24.4.2007];
Directive 2007/31/EC (fosthiazate) [Official Journal L 140 of 1.6.2007];
Directive 2007/50/EC (beflubutamid and Spodoptera exigua nuclear polyhedrosis virus) [Official Journal L 202 of 3.8.2007];
Directive 2007/52/EC (ethoprophos, pirimiphos-methyl and fipronil) [Official Journal L 214 of 17.8.2007];
Directive 2007/76/EC (fludioxonil, clomazone and prosulfocarb) [Official Journal L 337 of 21.12.2007];
Directive 2008/40/EC (amidosulfuron and nicosulfuron) [Official Journal L 87 of 29.3.2008];
Directive 2008/41/EC (chloridazon) [Official Journal L 89 of 1.4.2008];
Directive 2008/45/EC (metconazole) [Official Journal L 94 of 5.4.2008].
Directive 2008/66/EC (bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine) [Official Journal L 171 of 1.1.2008].
Directive 2008/69/EC (clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen) [Official Journal L 172 of 2.7.2008];
Directive 2008/70/EC (tritosulfuron) [Official Journal L 185 of 12.7.2008];
Directive 2008/91/EC (diuron) [Official Journal L 262 of 1.10.2008];
Directive 2008/107/EC (abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim) [Official Journal L 316 of 26.11.2008];
Directive 2008/108/EC (flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat) [Official Journal L 317 of 27.11.2008];
Directive 2008/113/EC (several micro-organisms) [Official Journal L 330 of 9.12.2008];
Directive 2008/116/EC (aclonifen, imidacloprid and metazachlor) [Official Journal L 337 of 16.12.2008];
Directive 2008/125/EC (aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol) [Official Journal L 344 of 20.12.2008];
Directive 2008/127/EC (several active substances) [Official Journal L 344 of 20.12.2008];
Directive 2009/11/EC (bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad) [Official Journal L 48 of 19.2.2009];
Directive 2009/25/EC (pyraclostrobin) [Official Journal L 91 of 3.4.2009];
Directive 2009/37/EC (chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin) [Official Journal L 104 of 24.4.2009];
Directive 2009/51/EC (nicosulfuron) [Official Journal L 127 of 26.5.2009];
Directive 2009/70/EC (difenacoum, didecyldimethylammonium chloride and sulphur) [Official Journal L 164 of 26.6.2009];
Directive 2009/77/EC (chlorsulfuron, cyromazine, dimethachlor, etofenprox, lufenuron, penconazole, tri-allate and triflusulfuron) [Official Journal L 172 of 2.7.2009];
Directive 2009/82/EC (tetraconazole) [Official Journal L 196 of 28.7.2009];
Directive 2009/115/EC (methomyl) [Official Journal L 228 of 1.9.2009];
Directive 2009/116/EC (paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3) [Official Journal L 237 of 9.9.2009];
Directive 2009/117/EC (paraffin oil CAS No 8042-47-5 [Official Journal L 237 of 9.9.2009];
Directive 2009/152/EC (carbendazim) [Official Journal L 314 of 1.12.2009];
Directive 2009/153/EC (hydrolysed proteins) [Official Journal L 314 of 1.12.2009];
Directive 2009/154/EC (cyflufenamid) [Official Journal L 314 of 1.12.2009];
Directive 2009/155/EC (metazachlor) [Official Journal L 314 of 1.12.2009];
Directive 2009/160/EU (2-phenylphenol) [Official Journal L 338 of 19.12.2009].

Annex II – Requirements for the dossier to be submitted for the inclusion of an active substance in Annex I:

Directive 93/71/EEC [Official Journal L 221 of 31.8.1993];
Directive 94/37/EC [Official Journal L 194 of 29.7.1994];
Directive 94/79/EC [Official Journal L 354 of 31.12.1994];
Directive 95/35/EC [Official Journal L 172 of 22.7.1995];
Directive 95/36/EC [Official Journal L 172 of 22.7.1995];
Directive 96/12/EC [Official Journal L 65 of 15.3.1996];
Directive 96/46/EC [Official Journal L 214 of 23.8.1996];
Directive 96/68/EC [Official Journal L 277 of 30.10.1996];
Directive 2001/36/EC [Official Journal L 164 of 20.6.2001].

Annex III – Requirements for the dossier to be submitted for the authorisation of a plant protection product:

Directive 93/71/EEC [Official Journal L 221 of 31.8.1993];
Directive 94/37/EC [Official Journal L 194 of 29.7.1994];
Directive 94/79/EC [Official Journal L 354 of 31.12.1994];
Directive 95/35/EC [Official Journal L 172 of 22.7.1995];
Directive 95/36/EC [Official Journal L 172 of 22.7.1995];
Directive 96/12/EC [Official Journal L 65 of 15.3.1996];
Directive 96/46/EC [Official Journal L 214 of 23.8.1996];
Directive 96/68/EC [Official Journal L 277 of 30.10.1996];
Directive 2001/36/EC [Official Journal L 164 of 20.6.2001].

Annex IV – Risk phrases:

Directive 2006/104/EC [Official Journal L 363 of 20.12.2006].

Annex V – Safety phrases:

Directive 2006/104/EC [Official Journal L 363 of 20.12.2006].

Annex VI – Uniform principles for the evaluation and authorisation of plant protection products:

Directive 97/57/EC [Official Journal L 265 of 27.9.1997];
Directive 2005/25/EC [Official Journal L 90 of 8.4.2005].

Related Acts

Programme for the evaluation of existing substances

Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [Official Journal L 15 of 18.1.2008].
This Regulation completes the programme of work on the gradual examination of active substances on the market and lays down rules for the submission and evaluation of applications for inclusion in Annex I to Directive 91/414/EEC. Two procedures are established: a regular procedure involving verification by the Member State of dossiers on the active substance concerned, and an accelerated procedure which can be followed in the case of non-inclusion of the active substance.

Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 379 of 24.12.2004].

Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 168 of 27.6.2002].

Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 55 of 29.2.2000].

Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market [Official Journal L 366 of 15.12.1992].

This Regulation lays down detailed rules governing the relationship between industry, the Member States and the Commission for the implementation of the first phase of the programme, covering an initial series of 90 active substances.

Green Paper on agricultural product quality

Green Paper on agricultural product quality

Outline of the Community (European Union) legislation about Green Paper on agricultural product quality

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Food safety: general provisions

Green Paper on agricultural product quality

The aim of this consultation is to ensure a strategic and regulatory framework for the protection of agricultural products and to promote their quality. In this respect, the Commission intends to open a wide discussion on the existing instruments, on how they could be improved and on new initiatives which could be considered. Three areas are being reviewed: farming requirements and marketing standards, existing quality schemes and certification schemes.

Document or Iniciative

Green Paper of 15 October 2008 on agricultural product quality [COM(2008) 641 final – Not published in the Official Journal].

Summary

Quality is the European farmers’ most potent weapon in facing competition from emerging countries. In Europe the quality of agricultural products rests on the highest levels of safety guaranteed by Community legislation throughout the whole of the food chain and on other aspects (methods and location of production, etc.).

Quality issues related to food safety which are already covered by other Community actions on nutritional labelling or animal welfare do not form part of this consultation.

Production requirements and marketing standards

Food produced in the European Union (EU) adheres to a range of farming requirements. The aim of these requirements is to ensure that all products placed on the market comply with hygiene and safety standards and also respond to a number of environmental, ethical, social, etc. concerns. Many of these farming requirements -those not referring to product hygiene and safety – do not necessarily apply in respect of imported foodstuffs. However, European consumers cannot distinguish between products which adhere to these standards and those which do not. In order to better inform consumers, it is important to ask stakeholders about the possibility of creating a symbol which indicates that a product has been produced in compliance with certain production rules or on the need to indicate the place of production (EU/Non-EU) of primary products.

European marketing standards replace the different national standards. Their aim is to help farmers to offer quality products which meet consumer expectations and facilitate price comparison fordifferent qualities of product. For the majority of agricultural products, they will take the form of regulations that lay down definitions of products, minimum product standards, product categories and labelling requirements. As part of the consultation, stakeholders are asked about the need to define and impose compulsory elements (farming requirements, quality classifications, etc.), reserved terms (term ‘farmhouse’, ‘mountain product’) at the European level and on the need to simplify the current marketing standards.

European quality schemes

The system of geographical indications ensures the protection of intellectual property. This system includes Protected Designations of Origin (PDO) and Protected Geographical Indications (PGI) which describe the characteristics (PDO) or the reputation (PGI) of a product which are connected to their geographical area of origin. For consumers, geographical indications guarantee authentic, quality products which meet their expectations. To benefit from a PDO, all stages of production should, in principle, have taken place in the geographical area of origin. In the case of a PGI only one stage of production will suffice (this is the case with spirits in particular). The Green Paper aims to identify the necessary means to improve and develop the system of geographical indications as well as to protect this system in third countries.

The system of Traditional Specialities Guaranteed (TSG) was created in 1992. The TSGs are agricultural products or foodstuffs that have traditional composition or that are produced using traditional raw materials or traditional methods of production. Since its creation, only 20 TSGs have been registered under this system. This relatively low number raises the question whether a better means of identifying and promoting traditional specialities exists.

Since the adoption of Regulation (EC) No 834/2007 on the production and labelling of organic products, the main challenge has been to create an internal market for organic food. At present the market for organic food functions essentially along national lines. It is important, therefore, to consider possibilities which would enable the creation of a genuine single market for organic food at the EU level.

The system aimed at promoting quality products originating from the outermost regions rests on the introduction of a logo. To obtain this logo, producers must adhere to a number of requirements defined in compliance with Community regulations or in their absence, international regulations. To what extent could trade organisations, following the example of Spain and France, adopt additional specific requirements aimed at improving the quality of regional products and increasing the volume of quality agricultural products originating from the outermost regions of the EU?

Should other systems emerge, for example to identify products of ‘high-nature value’ or ‘mountain’ products?

Quality certification schemes

For consumers, food quality certification schemes offer additional guarantees that the label claim can be relied on. These schemes concern not only compliance with compulsory production standards, but also requirements such as environmental protection, animal welfare, fair trade, religious or cultural considerations, farming methods, product origin, etc. These requirements have led to a multitude of certification schemes and quality labels which sometimes give rise to concerns about the transparency of the requirements of the systems in question, the reliability of the claims and the fairness of commercial relations. The Green Paper opens the debate on how to protect the consumer and avoid additional constraints and costs for producers.

Context

The Commission invites all organisations and citizens who have an interest in the quality of agricultural products to submit their contributions before 31 December 2008. These contributions will form a basis for developing a Communication (Commission document establishing strategic guidelines) which should be published in May 2009.

Improving communication on agricultural product quality

Improving communication on agricultural product quality

Outline of the Community (European Union) legislation about Improving communication on agricultural product quality

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Food safety: general provisions

Improving communication on agricultural product quality

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on agricultural product quality policy [COM(2009) 234 final – Not published in the Official Journal].

Summary

In this Communication, the Commission defines strategic orientations to improve, in the medium term, communication between farmers, buyers and consumers as regards agricultural product quality, to harmonise European Union (EU) rules on the quality of these products and to improve and simplify existing schemes and labels.

Marketing standards

Marketing standards guarantee fair competition and avoid the consumer being misled as to the characteristics of products. There are four types of information contained in current marketing standards:

  • a basic definition of the product identity (for example the definition of ‘butter’, ‘fruit juice’, etc.);
  • product classification (for example the minimum fat content of ‘semi-skimmed milk’ or ‘large’, ‘medium’ and ‘small’ classes of eggs, etc.);
  • reserved terms bestowing added value upon the product (for example what constitutes ‘first cold pressed’ olive oil or ‘traditional method’ sparkling wine, etc.);
  • labelling requirements concerning the origin or place of farming.

In the future, the Commission plans to:

  • establish a general basic standard. This would cover those matters where a voluntary approach might distort the internal market or where compulsory labelling is necessary to provide consumers with basic information about products;
  • extend labelling systems identifying the place of farming to products other than those which are covered at this time;
  • examine the feasibility of laying down optional reserved terms for ‘product of mountain farming’ and ‘traditional product’. The term ‘traditional product’ could replace the current system of ‘traditional specialities guaranteed’ which has not reached its full potential; and
  • contribute to developing international standards.

Geographical indications

Geographical indication schemes encourage high quality farming, safeguard protected names from unauthorised use and imitation, and help consumers by providing them with information about products’ specific attributes. At this time, there are three schemes (for wines, for spirit drinks, and for agricultural products and foodstuffs) and two instruments: the PDO (protected designation of origin) and the PGI (protected geographical indication).

After the consultation, the Commission plans to:

  • create a single register bringing together the three existing systems (wines, spirits, and agricultural products and foodstuffs), while preserving the specificities of each system; and
  • enhance the protection of geographical indications at international level.

Organic farming

Community legislation on organic farming was amended in 2007 as part of the 2004 action plan for organic farming.

In order to foster trade in organic products, the Commission:

  • has created a logo that will be mandatory for all organic products from 2010;
  • will work with third countries towards recognition for organic farming standards;
  • will contribute to improving the directives of the
    Codex Alimentarius
    on organic farming.

Certification schemes

National or private food quality certification schemes provide a guarantee that agricultural products comply with mandatory farming standards and meet requirements concerning the protection of the environment, animal welfare, etc., defined in the scheme’s specifications. However, they may confuse consumers and engender administrative costs and costs for farmers.

The Commission will establish, in consultation with the Advisory Group on Quality, good practice guidelines for private certification schemes in order to limit these drawbacks.

Context

This Communication is based on the consultation relating to the Green Paper on agricultural product quality published in October 2008, and on the High Level Conference organised on the same theme by the Czech presidency in March 2009.

The strategic orientations set out in this Communication offer a logical framework for the future policy on agricultural product quality. Comments from the other institutions but also from stakeholders will help to further refine and clarify these suggestions.

Maximum levels for certain contaminants

Maximum levels for certain contaminants

Outline of the Community (European Union) legislation about Maximum levels for certain contaminants

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Maximum levels for certain contaminants

Document or Iniciative

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs [See amending act(s)].

Summary

This Regulation lays down the maximum quantities for certain contaminants: nitrates, mycotoxins * (aflatoxins, ochratoxin A, patulin and Fusarium toxins), heavy metals (lead, cadmium, mercury), monochloro-propane-1, 2- diol (3-MCPD), dioxins and dioxin-type PCBs, polycyclic aromatic hydrocarbons (PAH) and inorganic tin.

Food with levels of contaminants higher than those specified in the Annex to the Regulation may not be placed on the market.

These maximum limits cover the edible part of food and also apply to compound or processed, dried or diluted foods, whereby a concentration or dilution factor may be applied or by taking into account the relative proportions of the ingredients in the compound product.

The Regulation also lays down the lowest maximum levels for contaminants which are reasonably achievable with good manufacturing practices or good agricultural practices (ALARA, As Low As Reasonably Achievable).

CONTAMINANTS

Nitrates

They are mainly present in vegetables (spinach, lettuce).

Some Member States are temporarily authorised to place on their national markets spinach and lettuce with levels of nitrates higher than those laid down in the Annex to the Regulation as long as these quantities remain acceptable in terms of public health. This transitional period is intended to allow the Member States affected to take the necessary steps to be able to comply with Community standards as quickly as possible.

The maximum levels of nitrates in vegetables are laid down according to the season.

The acceptable daily intake (ADI) laid down by the Scientific Committee on Food (SCF) is 3.65 mg/kg body weight.

Aflatoxins

These are genotoxic carcinogenic substances which develop at high temperatures and levels of humidity.

Sorting methods or other physical treatments enable the level of aflatoxins to be reduced for certain products such as groundnuts, nuts, dried fruit, maize and rice.

This Regulation permits higher levels of aflatoxins in these products if they are not intended for direct human consumption or use as an ingredient in food.

Ochratoxin A (OTA)

Ochratoxin A (OTA) is a mycotoxin produced by several fungi (penicillium and aspergillus species) with carcinogenic, nephrotoxic, teratogenic, immunotoxic and possibly neurotoxic properties. It has also been associated with nephropathy in humans.

It is naturally present in many crop products throughout the world, such as cereals, coffee beans, cocoa and dried fruit.

This Regulation lays down the maximum levels of the said substance for cereals, cereal products, raisins, roasted coffee, wine, grape juice, spices, liquorice and food for children.

The tolerable weekly intake (TWI) of ochratoxin A is 120 ng/kg body weight.

Patulin

Patulin is a mycotoxin produced by several types of fungus. It may be found in fruit juice, especially apple juice.

The provisional maximum tolerable daily intake for this substance is 0.4 ?g/kg body weight (bw).

Fusarium toxins

A variety of Fusarium fungi produces a number of mycotoxins * of the trichothecenes class, such as deoxynivalenol (DON), nivalenol (NIV), T-2 toxin, HT-2 toxin and some other toxins (zearalenone and fumonisins). Fusarium fungi are commonly found on cereals grown in the temperate regions of America, Europe and Asia. Several of the Fusarium fungi are capable, to a variable degree, of producing two or more of these toxins.

The SCF has adopted six opinions laying down a tolerable daily intake (TDI for these toxins. It established a TDI for deoxynivalenol of 1 ?g/kg body weight, a provisional TDI of 0.2 ?g/kg body weight for zearalenone, a TDI of 2 ?g/kg body weight for fumonisins, a provisional TDI of 0.7 ?g/kg body weight for nivalenol, a combined provisional TDI of 0.06 ?g/kg body weight for T-2 and HT-2 toxins and an opinion on trichothecenes as a group.

On the basis of these scientific opinions and the assessment of the dietary intake, this Regulation lays down the maximum levels for deoxynivalenol, zearalenone and fumonisins.

The Regulation states that the presence of T-2 and TH-2 may also be a public health concern. The Commission will therefore develop a reliable and sensitive method for detecting these toxins and continue to study the causes of their appearance in cereals and in particular in oats.

Lead

Lead absorption may constitute a serious risk to public health, since it may slow cognitive development, impair intellectual performance in children and increase blood pressure and cardiovascular diseases in adults.

The maximum level of lead in fish has been changed to 0.30 mg/kg fresh weight by the EU, taking account of the discussions within the .

Cadmium

Cadmium absorption also constitutes a risk to humans, since it may induce kidney dysfunction, skeletal damage and reproductive disorders.

Mercury

This substance may induce alterations in the normal development of the brain of infants and at higher levels may induce neurological changes in adults. It mostly contaminates fish and fishery products.

Methylmercury is the chemical form of mercury which is the greatest source of concern.

3-monochloropropane-1,2-diol (3-MCPD)

This carcinogenic substance is formed under certain conditions during food processing. In particular, it may be produced during manufacture of the food ingredient “hydrolysed vegetable protein” by the acid hydrolysis method.

By adjusting the production processes, the amount of 3-MCPD in the above-mentioned product has been reduced significantly. The main sources of exposures through food are soya sauce and soya sauce-based products.

The TDI is 2 µg/kg body weight.

Dioxins and dioxin-type polychlorinated biphenyls (PCBs)

Dioxins are chemicals resulting from certain natural phenomena (volcanism, forest fires) or industrial processes (manufacturing of pesticides, metals or paint, paper bleaching, incineration, etc.).

PCBs are chemicals which are widespread and found in, inter alia, building materials, lubricants, waterproofing agents and paints. Both types of substance may cause serious health problems, including cancer, immune and nervous system disorders, liver damage and sterility.

The TWI is 14 pg World Health Organisation toxic equivalent (WHO-TEQ)/kg body weight.

Polycyclic aromatic hydrocarbons (PAHs)

Some of these are genotoxic carcinogens. Contamination by PAHs may occur during smoking, heating and drying of food or through environmental pollution, especially in fish.

In order to protect public health, maximum levels are necessary for benzo(a)pyrene in certain foods containing fats and oils and in foods where smoking or drying processes might cause high levels of contamination. Maximum levels are also necessary in foods where environmental pollution may cause high levels of contamination, in particular in fish and fishery products, resulting, for example, from oil spills caused by shipping.

Inorganic tin

This type of tin may be found in tinned food and canned drinks. It may provoke gastric irritation in certain susceptible groups of the population.

For tinned foods other than beverages, the maximum level was laid down at 200 mg/kg. For canned beverages, the maximum level was laid down at 100 mg/kg.

BAN ON MIXING

Foods which comply with the maximum levels of contaminants may not be mixed with other foods which exceed these limits. By the same token, foods which must be sorted or subjected to other physical treatments to reduce the level of contamination may not be mixed with foods which comply with the maximum levels for human consumption.

SPECIFIC RULES ON LABELLING

Labelling on groundnuts, other oilseeds, nuts, dried fruit, rice and maize put on the market as foods which have to be subjected to sorting or other physical treatment before human consumption must include the wording: “product must be subjected to sorting or other physical treatments to reduce aflatoxin contamination before human consumption or use as an ingredient in foodstuffs”.

In addition, labelling on groundnuts, other oilseeds, products derived from oilseeds and cereals must indicate the use and lot identification code. If it is not clearly specified that they are not intended for human consumption, the maximum levels laid down by this Regulation apply.

The maximum levels defined in the Annex for lettuces “grown in the open” apply.

EXCEEDING OF THE LIMITS

Aflatoxins

Groundnuts, other oilseeds, nuts, dried fruit, rice and maize which exceed the maximum limits specified in the Annex to the Regulation may be placed on the market as long as:

  • they are not intended for human consumption;
  • they do not exceed the maximum limits for these products which are to be sorted before human consumption..

Nitrates

Derogations may be granted to some countries for exceeding the maximum level of nitrates. They cover production and consumption in the territory of the country concerned of products such as fresh spinach (Belgium, Ireland and the United Kingdom) and lettuces (Ireland and the United Kingdom).

Dioxins and dioxin-like PCBs

This Regulation grants Finland and Sweden a derogation for exceeding the levels of dioxins and dioxin-type PCBs until 31 December 2011 for the following products, but only for production and consumption in the territory of salmon, herring, river lamprey, trout, char and vendace roe from the Baltic.

CONTROL AND SUPERVISION

The Member States are responsible for supervising and controlling the level of nitrates in vegetables, especially green leaf vegetables.

They shall communicate the results to the Commission by 30 June every year.

Moreover, they shall communicate to the Commission the result of surveys carried out on the presence of contaminants in food every year

DISPOSAL OF STOCKS

This Regulation permits stocks of food which exceed the maximum levels of contaminants placed on the market before the date of entry into force of the respective limits for the contaminants to be disposed of.

MAXIMUM LEVELS IN FOOD FOR CHILDREN

This Regulation lays down maximum levels as low as possible for food for babies and for infants and young children in order to protect the health of this vulnerable population group. These maximum levels also apply to food for infants and young children covered by Directive 2006/125/EC and Directive 2006/141/EC.

The maximum levels for infants and young children according to this Regulation are:

  • nitrates: 200 mg/kg;
  • Aflatoxin B1: 0.10 µg/kg;
  • Aflatoxin M1: 0.025 µg/kg;
  • Ochratoxin A: 0.5 µg/kg and the same maximum level for dietary foods for specific medical purposes, specifically for infants;
  • Patulin: 10 µg/kg;
  • Deoxynivalenol: 200 µg/kg;
  • Zearalenone: 20 µg/kg and the same level for maize-based formulae for infants and young children;
  • Fumonisins: 200 µg/kg for maize-based formulae for infants and young children
  • Lead: 0.020 mg/kg fresh weight;
  • Inorganic tin: 50 mg/kg fresh weight and the same level for preparations for infant formulae and follow-on formulae and for canned dietary foods for special medical purposes specifically for infants (not including dried and powdered products);
  • benzo(a)pyrene: 1 µg/kg fresh weight and the same maximum level for formulae for infants and follow-on formulae and for dietary foods for special medical purposes specifically for infants.
Key terms used in the act
  • Mycotoxins Certain types of moulds of fungoid origin produce powerful poisons, especially the family of mycotoxins. The term mycotoxin comes from the Greek (mycos), which means fungus, and the Latin (toxicum), which means poison. It designates toxic chemical substances produced by certain moulds which develop on certain foodstuffs, particularly cereals.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1881/2006

9.1.2007

Applicable as of 1.3.2007

OJ L 364 of 20.12. 2006

Amending act(s) Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1126/2007

30.9.2007

OJ L 255 of 29.9.2007

Regulation (EC) No 629/2008

23.7.2008

OJ L 173 of 3.7.2008

Regulation (EC) No 165/2010

9.3.2010

OJ L 50 of 27.2.2010

The successive amendments and corrections to Regulation (EC) No 1881/2006 have been incorporated in the original text. This consolidated versionis of documentary value only.

Related Acts

METHODS OF SAMPLING AND METHODS OF ANALYSIS

Regulation (EC) No 333/2007 laying down methods of sampling and analysis for the official controls for the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs [Official Journal L 88 du 29.3.2007].

Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-type PCBs in certain foodstuffs [Official Journal L 364 of 20.12.2006].

Commission Regulation (EC) No 1882/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of the levels of nitrates in certain foodstuffs [Official Journal L 364 of 20.12.2006].

Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in food [Official Journal L 70 of 4.3.2006].
Amended by:
Regulation (EU) No 178/2010 [Official Journal L 52 of 3.3.2010].

IMPORTS

Commission Regulation (EC) No 1152/2009 of 27 November 2009 imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins and repealing Decision 2006/504/EC [Official Journal L 313 of 28.11.2009].

Biocides

Biocides

Outline of the Community (European Union) legislation about Biocides

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Biocides (until 1 September 2013)

Document or Iniciative

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 [See amending act(s)].

Summary

Scope

The Directive concerns:

  • the authorisation and placing on the market of biocidal products in the Member States;
  • the mutual recognition of authorisations within the Community;
  • the establishment at Community level of a list of active substances which may be used in biocidal products.

The Directive applies to biocidal products, i.e. non-agricultural pesticides as defined in Article 2 of the Directive. An exhaustive list of the products covered by this Directive is annexed below.

The Directive does not apply to products falling within the scope of the following legislative acts:

  • Directive 2001/83/EC (medicinal products for human use);
  • Directive 2001/82/EC (veterinary medicinal products);
  • Regulation (EC) No 726/2004 (European Medicines Agency);
  • Directive 90/385/EEC (active implantable medical devices)
  • Directive 93/42/EEC (medical devices);
  • Directive 98/79/EC (in vitro diagnostic medical devices);
  • Regulation (EC) No 1333/2008 (food additives)
  • Regulation (EC) No 1334/2008 (flavourings in foodstuffs);
  • Regulation (EC) No 1935/2004 (materials and articles intended to come into contact with foodstuffs);
  • Directive 90/167/EEC (medicated feedingstuffs);
  • Regulation (EC) No 767/2009 (feed);
  • Regulation (EC) No 1831/2003 (use of additives in animal nutrition);
  • Regulation (EC) No 1223/2009 (cosmetic products);
  • Regulation (EC) No 1107/2009 (plant protection products).

Obligations of the Member States

Member States must ensure the authorisation, classification, labelling, packaging and proper use of the biocidal products in line with this Directive. Proper use includes measures necessary to keep the use of biocidal products to a minimum as well as an obligation to ensure that their use in the workplace is in compliance with the directives on health and safety protection for workers. Member States must appoint one or more competent authorities responsible for complying with the obligations imposed on them under this Directive, including granting authorisations and receiving information relating to biocidal products so as to be able to meet any medical demand.

Each quarter Member States must inform the other Member States and the Commission of any biocidal products which have been registered and authorised within their territory or for which an authorisation or registration has been refused, modified, renewed or cancelled.

Every three years since 2003, Member States have submitted reports to the Commission in which they provide information on any poisonings involving biocidal products.

Principle of mutual recognition of authorisations

The authorisation system is based on the principle of mutual recognition of authorisations. Under this principle, a biocidal product that has already been authorised or registered in one Member State must be authorised in another Member State within 120 days or registered within 60 days of an application being received by the other Member State.

However, there are a number of derogations from mutual recognition:

  • The Member State may request that certain conditions relating to the classification, labelling and packaging of biocidal products be adapted under certain circumstances. These involve the quantity of the target species in the territory of the Member State, the degree of resistance of the target organism to the biocidal product and the circumstances under which it is used;
  • Where a Member State believes that a low-risk biocidal product which has been registered in another Member State does not comply with the definition set out in the Directive it may provisionally refuse to register it. In such cases it must notify the competent authority responsible for verifying the dossier;
  • Where a Member State believes a biocidal product authorised by another Member State does not meet the conditions for granting the authorisation and proposes to refuse the authorisation or registration it must notify the Commission, the other Member States and the applicant. The case will then be referred to the Standing Committee on Biocidal Products for a final decision which must be unanimously accepted;
  • Unless otherwise stated in the Treaty, Member States may refuse to grant mutual recognition of authorisations issued for types of products used against vermin, fish and birds, provided that such action is justifiable and does not frustrate the objectives of the Directive.

Conditions governing the granting of authorisations

It is compulsory to issue product marketing authorisation, subject to certain derogations in the case of low-risk products. The Member States may authorise a biocidal product only if:

  • its active substances are listed in the Annexes to the Directive and the requirements set out in the Annexes are met;
  • it is established that:
    • the biocidal product is sufficiently effective,
    • it has no unacceptable effects on the target organisms,
    • it has no unacceptable effects on human health or animal health or on surface water or groundwater,
    • it has no unacceptable effect on the environment;
  • the nature and quantity of its active substances can be determined according to the requirements listed in the Annexes to the Directive;
  • its physical and chemical properties have been deemed acceptable for purposes of appropriate use, storage and transport of the product.

A biocidal product classified as toxic, carcinogenic and mutagenic or toxic for reproduction is not authorised for marketing to the general public.

Authorisations may be reviewed at any time during the period for which they have been granted.

Placing on the market of active substances

An active substance for use in biocidal products may be placed on the market if:

  • a dossier has been submitted to a Member State accompanied by a declaration that the active substance is intended for inclusion in a biocidal product. This condition applies to active substances which did not have an authorisation to be placed on the market before 14 May 2000;
  • the active substance is classified, packaged and labelled in accordance with Directive 67/548/EEC which is applicable until 1 June 2015.

All active substances approved for inclusion in biocidal products are listed in Annex I or IA to the Directive. The maximum period during which a substance may be listed in the Annex is ten years.

Inclusion of a new active substance in the Annex

With a view to listing a new active substance in Annex I, IA or IB to the Directive, the Commission presents a proposal to the Standing Committee. The proposal is based on an evaluation of the substance carried out with the help of data supplied by the applicant.

Cancellation of an authorisation

An authorisation is cancelled if:

  • the active substance is no longer included in Annex I or IA to the Directive;
  • the conditions for obtaining the authorisation are no longer satisfied;
  • false particulars were supplied with the application for authorisation;
  • at the request of the authorisation holder.

Modification of an authorisation

An authorisation may be modified:

  • where a Member State considers that this is necessary to protect health and the environment;
  • at the request of the holder.

It is the responsibility of the holder of an authorisation for a biocidal product to pass on immediately to the competent authority any information of which he is aware concerning an active substance or a biocidal product containing it and which may affect continuing authorisation.

Procedure for requesting authorisation

An application for authorisation should come from the person initially responsible for placing a biocidal product on the market in a Member State and should be addressed to the competent authority in that Member State. In order to obtain the authorisation, the applicant must provide the following:

  • a dossier or letter of access concerning the biocidal product and containing the information specified in Annex IIB, IIIB or IVB depending on the type of biocidal product. The required information will contain, for example: the applicant’s name and address, the name and composition of the product, proposed uses, protective measures to be taken, among others. Dossiers for low-risk biocidal products are less detailed;
  • a dossier or letter of access for each active substance contained in the biocidal product and containing the information specified in Annexes IIA, IIIA and IVA.

The authorisation to place biocidal products on the market and entries of substances in Annex I, IA or IB are subject to the payment of a charge.

Member States may only use the information contained in the dossier accompanying the application for authorisation for the benefit of another applicant on certain conditions, one of which stipulates that the written agreement of the first applicant must be obtained.

Provisions applicable to a biocidal product that has already been authorised

Applicants for authorisation to place products on the market may use information provided by a previous applicant, in so far as the subsequent applicant can provide evidence that the product is similar and its active substances are the same as in the product previously authorised.

Before carrying out experiments involving vertebrate animals, an applicant for authorisation of a biocidal product must enquire of the competent authority of the Member State to which they intend to submit their application:

  • whether the biocidal product in question is similar to a biocidal product already authorised;
  • as to the name and address of the holder of the authorisation.

The applicant and holder or holders of former authorisations are encouraged to come to an agreement on the shared use of information to avoid duplicating the testing on vertebrate animals.

Exemptions

The Directive provides for the possibility of exemption from the requirements for placing biocidal products on the market. A Member State may temporarily authorise placing biocidal products on the market which do not comply with the provisions of the Directive for limited and controlled use if such measures appear necessary due to unforeseen danger not able to be contained by other means.

Role of the Commission

Following the adoption of the Directive, the Commission is to embark on a programme of work, systematically examining the risks associated with all active substances authorised for inclusion in biocidal products. The programme has been set up under a Regulation adopted by the Standing Committee on Biocidal Products, and will run for ten years. Its task is to examine all active substances already available on the market as of 14 May 2000 in the form of active substances for a biocidal product, with the exception of products used for purposes of research, science and product development.

Not more than two years prior to the completion of the programme of work, the Commission will send a progress report on the implementation of the programme to the European Parliament and the Council.

To further improve implementation of the Directive, the Commission must prepare technical guidelines which are to be published in the Official Journal of the European Communities.

Research and development

Experiments or tests carried out for the purposes of research or development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product are subject to several conditions, including an obligation to obtain authorisation from the competent authority if the tests are likely to have harmful effects on human or animal health or on the environment.

Classification, packaging and labelling

Biocidal products are classified, packaged and labelled in accordance with Directive 1999/45/EC on the classification, packaging and labelling of dangerous preparations which is applicable until 1 June 2015. However, in order to avoid any misunderstandings (confusion with foodstuffs or drinks, for example), the Directive lays down additional requirements with regard to the packaging and labelling of such products.

Safety measures

A system of specific information is introduced in order to enable professional and industrial users of biocidal products to take the necessary measures for the protection of the environment and health. This system must take the form of a data safety sheet provided by those responsible for placing the product on the market.

Confidentiality

The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.

Safeguard clause

The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.

Advertising

Marketing biocidal products is subject to certain conditions and must be in particular accompanied by wording which makes clear that the product should be used with care.

Comitology

The Commission is assisted by a Standing Committee on Biocidal Products. The Committee operates according to a regulatory procedure in the case of certain tasks, such as taking decisions to grant or withhold a prohibition (safeguard clause) or according to a management procedure in other cases, such as the listing of an active substance in the Annex and granting confidentiality.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Directive 98/8/EC

14.5.1998

13.5.2000

OJ L 123 of 24.4.1998

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1882/2003

20.11.2003

OJ L 284 of 31.10.2003

Directive 2007/47/EC

11.10.2007

21.12.2008

OJ L 247 of 21.9.2007

Directive 2008/31/EC

21.3.2008

OJ L 81 of 20.3.2008

Directive 2009/107/EC

26.10.2009

14.5.2010

JO L 262 du 6.10.2009

The successive amendments and corrections to Directive 98/8/EC have been incorporated into the basic text. This consolidated version  is for reference purpose only.

LAST AMENDMENTS TO THE ANNEXES

Annex I – List of active substances with requirements agreed at community level for inclusion in biocidal products
Directive 2011/10/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/11/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/12/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/13/EU [Official Journal L 34 of 9.2.2011].

Related Acts

Evaluation of active substances

Directive 98/8/EC provides for an evaluation of all active substances already on the market as at 14 May 2000 in the form of active substances in biocidal products. The ten-year programme is divided into two phases: the first, which began in 2000, is concerned with the identification of the substances, and the second, which began in 2003, with their evaluation.

Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products [Official Journal L 228 of 8.9.2000].
The first phase of this Regulation adopted on 7 September 2000 aims to:

  • identify the relevant substances and specify which need to be evaluated with a view to their possible listing in Annex I, IA or IB to Directive 98/8/EC (active substances authorised for use in biocidal products);
  • identify the first priority list of active substances to be evaluated during the second phase of the programme (the existing active substances used in biocidal products of type 8 (wood preservatives) and type 14 (rodenticides)).

Producers should identify the active substances to the Commission not later than 18 months after the entry into force of this Regulation using the special software provided free of charge by the Commission. Should the producer or formulator wish to request the listing of an active substance in Annex I or IA to the Directive, notification rather than identification will be necessary. The producer or formulator is required to provide the Commission with the information specified in Annex II to the Regulation, using the special Commission software, within 18-months of the Regulation’s date of entry into force. The Commission, in cooperation with the Member States, will then decide whether to accept or reject the notification. If it is accepted, the notifier must provide all the data and information necessary evaluating the active substance with a view to its possible inclusion in the Annex to the Directive during the second phase of the review programme.

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market [Official Journal L 325 of 11.12.2007].
This Regulation replaces and repeals Regulation (EC) No 2032/2003 of 4 November 2003, which had been subject to successive amendments. These various amendments made it difficult to read, particularly the Annexes concerning lists of identified active substances (Annexes I and VII to Regulation EC No 2032/2003), notified substances (Annexes II, V and VIII), and identified but not notified active substances (Annex III).
Regulation (EC) No 1451/2007 thus rationalises these lists and consolidates their successive amendments:

  • by creating an Annexe I, corresponding to the list of existing active substances, i.e. substances that are known to have been placed on the market as active biocidal substances before 14 May 2000 (consolidation of Annexes I and VII to the previous Regulation);
  • by creating an Annexe II, corresponding to the list of active substances currently notified to the review programme, updated, indicating the name of the reporting Member State (consolidation of Annexes II, V and VIII to the previous Regulation);
  • by deleting the former Annex III to the previous Regulation EC No 2032/2003, since it was no longer of use.

Application of the legislation

Report from the Commission to the Council and the European Parliament of 8 October 2008 – Evaluation of the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market (submitted in accordance with Article 18 (5) of the Directive) and progress Report on the work programme referred to in Article 16(2) of the same Directive [COM(2008) 620 – Not published in the Official Journal].
The Directive set the foundations for improving the level of environmental and public health protection which is offered to European Union citizens in relation to biocidal products. During the five years prior to the effective start of the active substance review in 2004, the Commission, in cooperation with the Member States and industry, inventoried biocidal products on the market and put into place a structured procedure for the assessment and evaluation of the existing active substances.
The review programme will not be finalised by the date originally set, 14 May 2010, which also happens to be the date by which national rules for the placing on the market of biocidal products will cease to apply. Allowing the transitional period to elapse without completing the review programme for biocidal products,would mean that the harmonised rules of the Directive about product authorisation could not apply for all the biocidal products already on the market. If neither set of rules – harmonised or national – could apply, there would be a legal void with regard to the placing on the market of biocidal products. This could have negative effects on public health (if important biocidal products were withdrawn from the market) and would have severe adverse economic effects on all companies operating in the biocides sector.
Therefore, this Communication is accompanied by a proposal for the revision of the Directive which would extend the review programme, the transitional period, and certain provisions on data protection that accompany this period for an additional three years.


Another Normative about Biocides

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Food safety > Plant health checks

Biocides

Document or Iniciative

Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Summary

This Regulation applies to:

  • biocidal products *;
  • articles and materials treated * with biocidal products;
  • active substances.

A list of the products concerned can be found in Annex V to the Regulation.

Conditions for authorisation of biocidal products

For biocidal products, the following conditions must be met for authorisation:

  • the active substance are approved for the relevant product-type;
  • the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
  • the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
  • where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
  • where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

An active substance shall be approved for a maximum initial period of 10 years if at least one biocidal product containing that active substance may be expected to meet the above criteria.

National authorisation and mutual recognition

The Regulation provides for harmonised procedures for the authorisation of biocidal products in the EU. Once a first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries. The authorisation shall be granted under identical terms and conditions.

Union authorisation

The centralised authorisation procedure will result in a Union authorisation which allows the industry to place biocidal products directly on the entire EU market without the need to obtain separate national authorisations or go through the mutual recognition procedure. This centralised authorisation is voluntary and if, for whatever reason, the applicant is not interested in a Union authorisation, he can instead apply for a national authorisation and, if appropriate, mutual recognition of that authorisation in other EU countries.

Simplified authorisation procedure

Certain biocidal products may be eligible for a simplified authorisation procedure, if the following conditions are met:

  • all the active substances contained in the biocide appear in and satisfy any restrictions in Annex I to this regulation;
  • the biocide does not contain any substance of concern or any nanomaterials;
  • the biocide is sufficiently effective;
  • the handling of the biocidal product and its intended use do not require personal protective equipment.

If the above conditions are met, applicants must submit applications to the European Chemicals Agency (ECHA), designating a competent authority to evaluate its application.

A biocidal product authorised by the above simplified procedure may be made available on the market in all EU countries without the need for mutual recognition. However, the authorisation holder must notify each EU country no later than 30 days before placing the product on the market within that country. The official language or languages of that country must be used on the product’s labelling, unless the country provides otherwise.

Treated articles

This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated or which incorporate a biocidal product. Articles can only be treated with active substances which have been approved in the EU for that purpose. Manufacturers and importers of treated articles are required to label products when:

  • a claim is made that the treated article has biocidal properties;
  • the conditions of the approval of the active substance used to treat the article require specific labelling provisions to protect public health or the environment.
KEY TERMS USED IN THE ACT
  • Biocidal products: any substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
  • Treated article: any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 528/2012

17.7.2012

OJ L 167 of 27.6.2012


Another Normative about Biocides

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Food safety > Contamination and environmental factors

Biocides

Document or Iniciative

Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Summary

This Regulation applies to:

  • biocidal products *;
  • articles and materials treated * with biocidal products;
  • active substances.

A list of the products concerned can be found in Annex V to the Regulation.

Conditions for authorisation of biocidal products

For biocidal products, the following conditions must be met for authorisation:

  • the active substance are approved for the relevant product-type;
  • the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
  • the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
  • where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
  • where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

An active substance shall be approved for a maximum initial period of 10 years if at least one biocidal product containing that active substance may be expected to meet the above criteria.

National authorisation and mutual recognition

The Regulation provides for harmonised procedures for the authorisation of biocidal products in the EU. Once a first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries. The authorisation shall be granted under identical terms and conditions.

Union authorisation

The centralised authorisation procedure will result in a Union authorisation which allows the industry to place biocidal products directly on the entire EU market without the need to obtain separate national authorisations or go through the mutual recognition procedure. This centralised authorisation is voluntary and if, for whatever reason, the applicant is not interested in a Union authorisation, he can instead apply for a national authorisation and, if appropriate, mutual recognition of that authorisation in other EU countries.

Simplified authorisation procedure

Certain biocidal products may be eligible for a simplified authorisation procedure, if the following conditions are met:

  • all the active substances contained in the biocide appear in and satisfy any restrictions in Annex I to this regulation;
  • the biocide does not contain any substance of concern or any nanomaterials;
  • the biocide is sufficiently effective;
  • the handling of the biocidal product and its intended use do not require personal protective equipment.

If the above conditions are met, applicants must submit applications to the European Chemicals Agency (ECHA), designating a competent authority to evaluate its application.

A biocidal product authorised by the above simplified procedure may be made available on the market in all EU countries without the need for mutual recognition. However, the authorisation holder must notify each EU country no later than 30 days before placing the product on the market within that country. The official language or languages of that country must be used on the product’s labelling, unless the country provides otherwise.

Treated articles

This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated or which incorporate a biocidal product. Articles can only be treated with active substances which have been approved in the EU for that purpose. Manufacturers and importers of treated articles are required to label products when:

  • a claim is made that the treated article has biocidal properties;
  • the conditions of the approval of the active substance used to treat the article require specific labelling provisions to protect public health or the environment.
KEY TERMS USED IN THE ACT
  • Biocidal products: any substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
  • Treated article: any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 528/2012

17.7.2012

OJ L 167 of 27.6.2012