Tag Archives: Labelling

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].

Accession of the European Community to the Codex Alimentarius Commission

Accession of the European Community to the Codex Alimentarius Commission

Outline of the Community (European Union) legislation about Accession of the European Community to the Codex Alimentarius Commission

Topics

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

Food safety > International dimension and enlargement

Accession of the European Community to the Codex Alimentarius Commission

Document or Iniciative

Council Decision 2003/822/EC of 17 November 2003 on the accession of the European Community to the Codex Alimentarius Commission [Official Journal L 309, 26.11.2003].

Summary

Context

The Codex Alimentarius (or food code) is a joint programme of the FAO (the UN’s Food and Agriculture Organisation) and the WHO (World Health Organisation), which lays down food health standards that serve as a reference for international trade in foodstuffs.

Since 1994 and the entry into force of the WTO Agreements on Sanitary and Phytosanitary Measures (SPS Agreement) and on Technical Barriers to Trade (TBT Agreement), the legal relevance of the Codex standards has increased. Indeed these two Agreements make reference to those standards, meaning that the latter are used as the basis for the evaluation of national measures and regulations.

At present, all Member States of the European Union (EU), and, since the end of 2003, the European Community as such are members of the Codex Alimentarius Commission, which is the body in charge of updating the Codex.

This Decision concerns the application of the European Community to accede to the CAC, achieved in 2003. It is accompanied by a declaration on the exercise of competence between the European Community and its Member States and by the text of the Arrangement between the Council and the Commission regarding preparation for meetings and statements and the exercise of voting rights within the CAC.

Background to the accession negotiations

Since Article 2 of the CAC’s statutes authorises any FAO member to become a full member, the European Community started negotiations to that end in the mid-1990s.
In January 1994, the Council authorised the Commission to enter into negotiations, on behalf of the Community, with the CAC Secretariat with a view to defining the conditions and procedures for the Community’s accession.
Discussions between the Commission and Council had since then been blocked by Member State concerns about internal coordination and the division of responsibilities.
As a result of the White Paper on Food Safety, which reaffirmed the benefits of CAC membership, negotiations with the CAC Secretariat on accession conditions resumed during 2001.

In June 2003, the CAC amended its Rules of Procedure allowing regional economic integration organisations to become members, thus opening the way to the accession of the European Community alongside its Member States.

The Codex Alimentarius Commission: aims and mode of operation

The CAC was created by the WHO and FAO in 1963 to implement their Joint Food Standards Programme aimed at protecting the health of consumers, ensuring fair trade practices in the food trade and promoting coordination of all food standards work undertaken by governmental and international organisations.

Its main aim, then, is to define international standards, codes of practice and other guidelines and recommendations concerning agricultural and fishery products, foodstuffs, food additives, food contaminants, animal feed and the residues of veterinary products and pesticides as well as labelling, inspection and certification systems, analysis and sampling methods, ethics and good farming practice codes and food hygiene practices.
These standards are then published in one of the Codex’s 13 volumes:

  • general requirements and general requirements for food hygiene;
  • general texts on pesticide residues in food and maximum limits for same;
  • residues of veterinary drugs in foods;
  • foods for special dietary uses, including foods for infants and children;
  • processed and quick-frozen fruits and vegetables, fresh fruits and vegetables;
  • fruit juices;
  • cereals, pulses and derived products and vegetable proteins;
  • fats and oils and related products;
  • fish and fishery products;
  • meat and meat products;
  • soups and broths;
  • sugars, cocoa products and chocolate and miscellaneous products;
  • milk and milk products;
  • methods of analysing and sampling.

The CAC’S work also encourages food traders to voluntarily adopt ethical practices. To that end, the CAC has published a Code of ethics for international trade in food, which now forms part of the Codex.

The CAC currently comprises 171 countries and holds meetings every year. It is helped in developing its standards by subsidiary bodies, which include committees dealing with horizontal matters (for example, general principles, labelling, food hygiene, food additives and contaminants, etc.), committees dealing with vertical matters, i.e. specialising in one type of product (for example, milk and milk products, fish and fishery products, etc.), “task forces” dedicated to a particular task of limited duration and regional coordinating committees. In addition, the experts’ meetings organised and supported by the FAO and the WHO provide the essential scientific basis (risk assessment) for the CAC’S work and the publications resulting from their activities act as international references. There are three of these groups of experts, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), the Joint FAO/WHO Meeting on Microbiological Risk Assessment (JEMRA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Activities of the European Community and its Member States within the CAC

The CAC’s Rules of Procedure now allow a member organisation to share its voting rights with its Member States in accordance with their respective competences. When the member organisation is entitled to vote, the number of votes it may cast is equal to the number of Member States present when the vote is taken, hence the importance of Member States being present. This rule is the result of a compromise reached with developing countries, which, in the interests of fairness, could not accept the vote of a country not present being counted.

Competence is assigned as follows:

  • the European Community has exclusive competence for matters on which the rules have already been harmonised, either fully or to a large extent, at Community level. In such cases, the Commission speaks and votes in the name of the Community, although Member States have the right to speak in favour of the Community position and to react to contributions from other countries;
  • the Member States have exclusive competence for all organisational matters (for example, legal or budgetary questions) and for procedural matters (for example, the election of chairpersons, the adoption of agendas and the approval of minutes);
  • competence is shared where rules have been only partially harmonised: the vote is exercised either by the Member States or the Community, depending on the degree of harmonisation achieved. In such cases, the Presidency and the Commission put forward the common position. Member States may also speak in order to support and/or develop the Community position and to react to contributions.

Before each meeting of the CAC or of one of its subsidiary bodies, an annotated agenda, indicating who, within the organisation or its Member States, is competent for each item and is to exercise the right to vote, is drawn up and given to all participants.

In addition, the Member States and the Commission have the right to participate in the Codex working groups and drafting committees and express their opinions there. Member State and Commission representatives endeavour to reach a common position and defend this during discussions in the working groups and drafting committees,

The HACCP principles (Hazard Analysis and Critical Control Point) and the Codex Alimentarius

The measures taken by the EU with regard to food safety and food frequently invoke the Codex as justification. This is true particularly of the HACCP principles, which are the basis of European legislation relating to food hygiene and official controls on products of animal origin intended for human consumption.

These principles, developed by the CAC since the early 1990s, prescribe a number of stages to be followed throughout the production cycle in order to allow, on the basis of a risk analysis, the identification of critical points that need to be monitored to ensure food safety:

  • identification of all risks to be avoided, eliminated or reduced to acceptable levels;
  • identification of the critical or limit points where surveillance becomes essential;
  • establishment and application of effective procedures for monitoring critical points;
  • adoption of corrective measures when monitoring reveals a critical point is being overstepped.

Relationship between the WTO and the Codex Alimentarius

When the WTO was set up in April 1994, two specific agreements were concluded in Marrakech to restrict barriers to trade justified on the basis of protectionist technical regulations:

  • the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement);
  • the Agreement on Technical Barriers to Trade (TBT Agreement).

The SPS Agreement lays down the conditions on which a State can adopt and implement health measures (animal health, food safety) or phytosanitary measures (protection of plants) that have a direct or indirect impact on international trade. This Agreement makes explicit reference to the standards defined by the Codex to impose limits on the actions of the signatory States.
Thus the preamble to this Agreement declares itself in favour of furthering “the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organisations, including the Codex Alimentarius Commission”.

The TBT Agreement aims to guarantee that technical regulations and standards do not create unnecessary obstacles to international trade. It too makes extensive reference to international standards, though without explicitly citing the Codex, in the context of the harmonisation that it advocates.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Decision 2003/822/EC 17.11.2003 OJ L 309 of 26.11.2003

Textile products: textile fibre names and labelling

Textile products: textile fibre names and labelling

Outline of the Community (European Union) legislation about Textile products: textile fibre names and labelling

Topics

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

Enterprise > Industry

Textile products: textile fibre names and labelling

Document or Iniciative

Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (Text with EEA relevance).

Summary

This Regulation lays down provisions relating to:

  • textile fibre names * with regard to their definition and use when indicating the fibre composition of textile products;
  • the labelling of textile products * containing non-textile parts of animal origin;
  • methods of analysis to check information indicated on labels or markings.

Products concerned by the Regulation

The Regulation concerns textile products, namely:

  • products containing at least 80 % by weight of textile fibres;
  • products treated in the same way as textile products.

The Regulation does not concern textile products contracted out to persons working in their own homes or to independent firms without property being transferred, or to textile products made up by self-employed tailors.

Textile fibre names

The description of fibre composition of textile products must use the textile fibres listed in Annex I to the Regulation. The Regulation states which names shall correspond to which type of fibre. The use of these names for other fibres is prohibited.

Manufacturers may ask the European Commission to include a new textile fibre name in Annex I to the Regulation. A technical file must be submitted with their application, drawn up pursuant to Annex II and containing the following information:

  • the proposed name, definition and identification for the new textile fibre;
  • sufficiently developed identification and quantification methods;
  • additional information concerning possible allergic reactions, the production process and consumer relevance.

Indication of the composition of textile products

The use of the terms “100 %”, “pure” or “all” is limited to products composed of a single textile fibre.

The terms “virgin wool” or “fleece wool” (and the terms listed in Annex III) may be used on labels provided the product is composed exclusively of a wool fibre which has not previously been incorporated in a finished product, and which has not been subjected to any spinning. If wool is contained in a mixture of textile fibres, the term “virgin wool” may appear on labelling if:

  • all the wool is composed of a single wool fibre;
  • such wool accounts for no less than 25 % of the total weight of the mixture;
  • the wool is mixed with only one other fibre in the case of a scribbled mixture.

Textile products composed of several fibres must be labelled with the name and percentage by weight of all constituent fibres, in descending order. The term “other fibres” may be used if some minor fibres could not be stated at the time of manufacture of the product, or for fibres not listed in Annex I. The terms “mixed fibres” or “unspecified textile composition” may be used on a textile product the composition of which is hard to state at the time of manufacture.

The presence of non-textile parts of animal origin in textile products must be indicated by the phrase “Contains non-textile parts of animal origin” on the labelling.

Labelling and marking of textile products

When placed on the market, textile products shall be labelled and marked in a durable, legible, visible and accessible way, to indicate their fibre composition. For products not intended for the final consumer, such labelling or marking may be replaced with accompanying commercial documents. They shall then be provided by the product manufacturer.

For textile products consisting of two or more textile components not having the same textile fibre composition, the fibrous composition for each component must be indicated.

Labelling must not include abbreviations. Labels must also be offered in one or more of the official languages of the Member State within which the product has been placed on the market.

Economic operators placing textile products on the market are responsible for their labelling or marking.

Descriptions of textile fibre composition must also appear in catalogues, trade literature, and packaging. Such information must be visible for online purchases.

Labelling is not mandatory for the products listed in Annex V.

Market surveillance

Checks on the conformity of the fibre composition of textile products shall be carried out by market surveillance authorities, according to the methods described in Annex VIII.

As from 8 May 2012, this Regulation repeals Directives 73/44/EEC, 96/73/EC and 2008/121/EC.

Key terms of the Act
  • Textile fibre: a unit of matter characterised by its flexibility, fineness and high ratio of length to maximum transverse dimension, which render it suitable for textile applications, or a flexible strip or tube, of which the apparent width does not exceed 5 mm, including strips cut from wider strips or films, produced from the substances used for the manufacture of the fibres listed in Table 2 of Annex I.
  • Textile product: any raw, semi-worked, worked, semi-manufactured, manufactured, semi-made-up or made-up product which is exclusively composed of textile fibres, regardless of the mixing or assembly process employed.

Reference

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

Regulation (EU) No 1007/2011

7.11.2011

OJ L 272, 18.10.2011

Traditional specialities guaranteed

Traditional specialities guaranteed

Outline of the Community (European Union) legislation about Traditional specialities guaranteed

Topics

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

Internal market > Businesses in the internal market > Intellectual property

Traditional specialities guaranteed

This Regulation establishes the criteria and procedures by which agricultural products intended for human consumption and foodstuffs can be recognised as traditional specialities guaranteed (TSGs).

Document or Iniciative

Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed.

Summary

An agricultural product intended for human consumption or foodstuff with a traditional composition, or produced according to a traditional production method may become a traditional speciality guaranteed * (TSG). This possibility encourages the diversification of agricultural production and has positive consequences in several areas. The introduction of a TSG boosts farmers’ revenues and maintains the population in less favoured or remote areas by promoting the rural economy. It also increases the market value of the products of economic operators, by guaranteeing that they are distinguishable from other similar products or foodstuffs. In addition, thanks to the introduction of this designation, consumers will able be to make more informed choices on the basis of clear information on the specific characteristics of the products they buy.

Register of products

TSGs recognised at European level are entered into a register, which is kept by the Commission. They are divided into two lists according to whether or not the use of the name is reserved to those producers who comply with the product specification. A product may only be registered if:

  • it is produced using traditional raw materials;
  • it is characterised by a traditional composition or by a method of production/processing that corresponds to a traditional production/processing method.

In order to be registered, the name must:

  • be specific in itself;
  • indicate the specific character of the agricultural product or foodstuff.

Names that refer only to claims of a general nature used for a set of products or provided for by a particular piece of European legislation, and names that are misleading for consumers cannot be registered. In addition, these rules apply without prejudice to European rules governing intellectual property or concerning geographical indications and trademarks.

Product specification

In order to be recognised as a TSG, an agricultural product or foodstuff must comply with the product specification, and must include the following elements:

  • the name, given in one or more languages, and an indication whether the application for registration is being made with or without reservation of the name;
  • the description of the product, with an indication of its main physical, chemical, microbiological and organoleptic properties;
  • the description of the production method to be applied by the producers, including where relevant the nature and characteristics of the raw materials or ingredients used and the manufacturing method;
  • the key elements that define the product’s specific character;
  • the key elements that demonstrate the product’s traditional character;
  • the minimum requirements and procedures for checking its specific character.

Application for registration

The application for registration may be made only by a group of producers or processors. A joint application may be submitted by several groups originating from different Member States or third countries.

The application for registration must include:

  • the name and address of the applicant group;
  • the product specification;
  • the name and address of the authorities or bodies verifying compliance with the provisions of the product specification and their specific tasks;
  • the documents that demonstrate the specific nature and traditional character of the product.

Applications are to be lodged with the Member State where a group is established. The Member State examines it and initiates a national objection procedure, ensuring adequate publication of the application and providing for a reasonable period in which any natural or legal person having a legitimate interest and established or resident on its territory may lodge an objection. Then it forwards the completed application to the Commission, including a declaration that all the conditions have been met.

Where an application for an agricultural product or foodstuff comes from a group in a third country, it has to be sent to the Commission either directly or through the authorities of that country.

Examination by the Commission

The Commission shall check, within a maximum of twelve months, that the application is justified and that it meets all the necessary conditions. Each month, it makes public the list of the names for which registration applications have been submitted. If the conditions are met, it publishes in the Official Journal of the European Union the name and address of the applicant group, the product specification and the name and address of the authorities or bodies verifying compliance with the provisions of the product specification. If the conditions are not met, the Commission will reject the application for registration.

Objections

Within six months from the date of publication in the OJ, any Member State, third country, natural or legal person having a legitimate interest may object to the registration proposed by lodging a duly substantiated statement. They must show that either the conditions have not been meet, or that the name is already in lawful use, is renowned and is economically significant for similar agricultural products or foodstuffs.

Where the Commission receives no admissible objection, it will register the name.

Where the Commission judges the objection to be admissible, it invites the interested parties to engage in the appropriate consultations. If they reach an agreement within six months, they notify the Commission of all the factors that enabled that agreement to be reached, including the opinions of the applicant and the objector. If no agreement is reached, the Commission takes a decision, bearing in mind traditional fair practice and the actual likelihood of confusion. If the Commission takes the view that compliance with the conditions of the product specification of an agricultural product or foodstuff registered as a TSG is no longer ensured, it must initiate the procedure for cancelling the registration.

Amending the product specification

A group established on the territory of a Member State or in a third country may submit a request to the Commission for the amendment of a product specification either directly or through the authorities of the country in question.

Names, indication and symbol

Only producers complying with the product specification may refer to a TSG on the labelling, advertising or other documents relating to an agricultural product or foodstuff. Where reference is made to a traditional speciality guaranteed on the labelling of an agricultural product or foodstuff produced within the Community, the registered name is to be accompanied either by the Community symbol or the indication “traditional speciality guaranteed”. From the date of publication, all names entered in the register must be used in accordance with the rules stated above.

Registered names may be used in labelling, even if they do not correspond to the product specification. In such cases, it is not permitted to indicate “traditional speciality guaranteed”, the abbreviation “TSG”, or the associated Community symbol on the labelling. In addition, at the group’s request, a TSG may be registered with reservation of the name, unless the same name is already in lawful use, is renowned and is economically significant for similar agricultural products or foodstuffs.

Official controls

The control of the obligations established by this Regulation may be carried out by authorities designated by the Member States or by a control body operating as a product certification body. The costs of such verification are to be borne by the operators subject to those controls. In respect of agricultural products and foodstuffs originating from a third country, verification of compliance with the product specification must be ensured by one or more public authorities designated by the third country or by one or more product certification bodies.

A producer intending to produce a traditional speciality guaranteed for the first time must notify this fact to the authorities of the Member State. A third country producer intending to produce a traditional speciality guaranteed for the first time must notify this fact to the designated authorities or bodies.

Protection

The Member States must take the necessary measures to ensure legal protection against any misuse or misleading use of the term “traditional speciality guaranteed”, the abbreviation TSG and the associated Community symbol and against any imitation of names registered and reserved. Registered names must be protected against any practice liable to mislead the consumer, including practices suggesting that a product is a traditional speciality guaranteed recognised by the Community.

Committee procedure

The Commission is assisted by the Standing Committee on Traditional Specialties Guaranteed (FR).

Fees

The Member States may charge a fee to cover their costs, including those incurred in examining applications for registration, statements of objection, applications for amendments and requests for cancellations under this Regulation.

Key terms used in the act
  • Traditional speciality guaranteed (TSG): this designation does not refer to an origin, but highlights the traditional composition or means of production of the product.

References

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

Regulation (EC) No 509/2006

20.4.2006

OJ L 93 of 31.3.2006

Related Acts

Commission Regulation (EC) No 1216/2007 of 18 October 2007 laying down detailed rules for the implementation of Council Regulation (EC) No 509/2006 on agricultural products and foodstuffs as traditional specialities guaranteed [Official Journal L 275 of 19 October 2007].
This Regulation specifies the rules for the application of Regulation (EC) No 509/2006. It contains the forms relating to traditional specialities guaranteed, including the model for applying registration of a traditional speciality guaranteed. It also contains the logos used to mark these products.

Production and labelling of organic products

Production and labelling of organic products

Outline of the Community (European Union) legislation about Production and labelling of organic products

Topics

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

Environment > Tackling climate change

Production and labelling of organic products

Document or Iniciative

Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 [See amending act(s)].

Summary

This Regulation lays down a new legal framework for organic products. It sets out the objectives and principles applicable to this type of production and illustrates the rules on production, labelling, controls and trade with third countries. This Regulation enters into application on 1 January 2009.

Scope

The framework established by this Regulation governs:

  • agricultural products (including aquaculture products), either processed or unprocessed and intended for human consumption;
  • animal feed;
  • vegetative propagating material and seed used for crops;
  • yeasts used as food or feed.

This Regulation contains the basic objectives and general principles for organic farming. The objectives focus on sustainable agriculture and production quality, which must meet consumers’ needs. The general principles concern, inter alia, specific production methods, the use of natural resources and stringent restrictions on synthetic chemical inputs. Furthermore, the Regulation lays down specific principles concerning farming, the processing of organic food and organic animal feed.

Production rules

According to the general rules for organic production, genetically modified organisms (GMOs) are prohibited in all their forms. Rules concerning the labelling of food allow operators to ensure compliance with this prohibition. Treatment by ionising radiation is also prohibited.

Those wishing to operate both types of agricultural production (organic and non-organic) must ensure that animals and land for these two activities are separated.

Organic plant production must comply with certain rules concerning:

  • ground treatment, which must preserve life and the natural fertility of the ground;
  • the prevention of damage, which must be based on natural methods but which can make use of a limited number of plant protection products authorised by the Commission;
  • seed and plant propagation material, which must be produced using organic methods;
  • cleaning products, for which authorisation must be requested from the Commission.

Wild plants collected in some areas are also classified as organic products if they comply with certain conditions relating to their harvest and provenance. Seaweed may also be considered as an organic product as long as its area of production and harvest comply with certain conditions.

Organic livestock production must comply with certain rules concerning:

  • the animals’ origin – they must have been born and reared in organic holdings;
  • livestock husbandry practices, which, inter alia, relate to certain features of animal housing;
  • animal breeding methods, generally natural;
  • animal feed, which must be organic;
  • the prevention of disease;
  • cleaning and disinfection, involving the exclusive use of products authorised by the Commission.

Similar specific rules apply to aquaculture animals.

The Commission authorises the use of a limited number of products and substances in organic farming. These products may be for plant care, animal feed and the cleaning of buildings used for livestock and plant production. The Commission may also set certain limits and conditions for the application of these products.

Holdings which are entering into a new organic farming activity must comply with a conversion period. The rules laid down in this Regulation also govern this conversion period.

Organic processed feed must contain organic raw materials and may not be processed using chemical solvents. Processed food must contain mainly ingredients of agricultural origin. Other ingredients are permitted if authorisation has been requested from the Commission. Organic yeast must be produced from organic substrates and other authorised ingredients.

The Commission may make exceptions to provisions concerning objectives, production rules and labelling. These exceptions will be limited in time and apply to certain particular cases.

Labelling

Labelling, advertising or commercial documents may use terms such as “eco” and “bio” to describe an organic product, its ingredients, or raw materials.

The labelling of an organic product must be clearly visible on the packaging and contain a reference to the control body that certifies the product concerned.

From 1 July 2010, the use of the European Union logo on organic food products will be mandatory, as will an indication of the provenance of raw materials used in the product. This indication must be shown in the same field of vision as the Community logo.

Controls

Compliance with the provisions contained in this Regulation will be guaranteed by a system of controls based on Regulation (EC) No 882/2004 and precautionary and control measures established by the Commission. This system guarantees the traceability of food pursuant to Regulation (EC) No 178/2002.

An assessment of the risk of infringement will determine the type and frequency of controls. These will be organised by authorities appointed by Member States. Under certain conditions, these authorities may delegate control duties to accredited bodies, but they shall remain responsible for the supervision of the controls carried out and the granting of exemptions. Member States must notify the Commission regularly of the list of authorities and control bodies (list of bodies or authorities responsible for control published in 2007 ).

The authorities must also control the activities of each operator involved in the marketing of an organic product before it is placed on the market. Following this control, the operator receives documentary evidence which certifies that it complies with the provisions of this Regulation. If irregularities are noted, the authority shall ensure that the labelling of the products at issue do not contain any reference to organic production.

Trade with third countries

Products from third countries may also be placed on the Community market as organic products as long as they comply with the provisions of this Regulation and if they have been subject to control. This control may be carried out either by a body recognised by the European Community, or by an accredited control body.

Marketing and statistical surveillance

The marketing of an organic product may not be hindered in any way by any authority of a Member State other than the authority which has inspected the product.

The Commission carries out statistical surveillance activities based on the data provided by Member States. The Standing Committee on Organic Farming assists the Commission in defining policies for organic farming.

Context

This Regulation has been produced as part of a series of initiatives to foster organic farming. In the same framework, the Commission adopted an Action Plan for Organic Food and Farming in 2004.

The first legal framework for organic farming was laid down in 1991 with Regulation (EC) No 2092/91. Since its adoption, several amendments have been introduced into this Regulation, because organic farming has become more and more important in all Member States (annual growth for this sector is estimated at almost 25 % between 1993 and 1998 and around 30 % since 1998). A report on organic farming will be published by the end of 2011.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 834/2007

27.7.2007

OJ L 189 of 20.7.2007

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 967/2008

10.10.2008

OJ L 264 of 3.10.2008

Related Acts

Rules for implementation

Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control [Official Journal L 250 of 18.9.2008].

Debate on the eco-labelling of fisheries products

Debate on the eco-labelling of fisheries products

Outline of the Community (European Union) legislation about Debate on the eco-labelling of fisheries products

Topics

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

Maritime Affairs And Fisheries > Management of fisheries resources and the environment

Debate on the eco-labelling of fisheries products

At the end of June 2005 the Commission launched a debate on a Community approach towards eco-labelling schemes for fisheries products. It evaluates the current situation as regards eco-labelling and puts forward objectives, accompanied by available options for the level of regulation by the public authorities.

Document or Iniciative

Commission Communication to the Council, the European Parliament and the European Economic and Social Committee – “Launching a debate on a Community approach towards eco-labelling schemes for fisheries products” [COM(2005) 275 final – Not published in the Official Journal].

Summary

The need to discuss eco-labelling * schemes was first addressed in a Commission Communication on the Future for the Market on Fisheries Products in the EU in December 1997. However, no progress was made on the issue due to differing views on how a common approach should be implemented. The importance of ensuring more sustainable exploitation of the marine environment has since increased considerably with the introduction in 2002 of the reformed Common Fisheries Policy. As consumers are demonstrating a growing interest in these labels and as significant progress has already been made, eco-labelling seems to be one way of further integrating the environmental aspects of the Common Fisheries Policy. The progress made as part of this policy opens up the issue of eco-labelling schemes.

The recent increase in the number of eco-labelled products creates difficulties in terms of competition, trade and consumer protection policies and has put the issue back on the agenda.

International momentum has also been created with the adoption of the United Nations Food and Agriculture Organisation (FAO) guidelines on “eco-labelling for fish and fisheries products from marine fisheries” and attention should be given to the work in the FAO and the World Trade Organisation (WTO) on this issue.

Existing eco-labelling schemes

Existing schemes use different certification criteria, and in some cases are liable to cause market access problems. There prove to be reserves on the part of developing countries which fear their products may be excluded from the markets of developed countries. Furthermore, it is not always easy to ascertain the credibility of environmental claims displayed on the labels and the criteria used for issuing the label.

Work on eco-labelling in international fora

Despite the commitment under the Doha Development Agenda, the debate within the WTO has still not resulted in a better synergy between trade, development and environment policies. However, the FAO Committee on Fisheries adopted guidelines for eco-labelling at its 26th meeting in March 2005. The Commission was involved in drawing up these guidelines and fully supports them.

Objectives of a Community approach

The Commission considers that eco-labelling must stimulate consumer awareness of the environmental dimension of fishing and thereby give managers in the sector the financial incentive to go above and beyond the requirements of existing ecology rules. The Community policy should ensure:

  • sustainable fisheries and an adequate level of protection of the ecosystem;
  • a harmonised approach throughout the Community;
  • transparent and objective information for consumers. Information must be clear and verifiable in accordance with the consumer protection policy;
  • fair competition;
  • labelling schemes are not prohibitive for small and medium enterprises or developing countries.

Possible levels of regulation

The Commission feels there are three options. The public authorities therefore have the choice between:

  • non-action;
  • creating a single Community eco-labelling scheme;
  • establishing minimum requirements for voluntary private and/or public eco-labelling schemes.

Having assessed the advantages and disadvantages of each option, the Commission is in favour of the third one as it would offer enough flexibility and would be proportionate in terms of costs. It would also offer an appropriate level of consumer protection.

The key points of the assessment carried out by the Commission include:

  • The cost in terms of the administrative resources needed for action by the public authorities, and the expertise needed within the public authorities to take this action.
  • Ease of access to the schemes for small and medium sized enterprises and developing countries.
  • The transparency, credibility and reliability of the assessments carried out by eco-labelling schemes.
  • Integration into a certification procedure carried out by a third party.
  • The risk of market distortion, or even fragmentation, and restrictions on the free circulation of goods and on market access.
  • A division between private sector initiatives and public sector regulatory activities.
  • The flexibility of the schemes and therefore their ability to adapt their requirements to any developments without being discriminatory.
  • The coherence between various schemes which apply different criteria for awarding their eco-label, such as ecological stock management, protecting the ecosystem or the fishing technique used.

The debate

Before arriving at a real Community approach to eco-labelling a debate must be held on some key questions, such as:

  • What should an eco-labelling scheme certify?
  • How to ensure a non-contradictory approach whilst simultaneously offering a high degree of voluntary participation and feasibility?
  • How to use fully the potential of schemes to promote sustainable fisheries, while yielding real benefits for fishermen, processors and consumers?
  • Should the approach be more result oriented or means oriented?

Background

This Communication invites the Council, the European Parliament, the Economic and Social Committee, the members of the European Economic Area and all interested parties to participate in the debate on a Community eco-labelling policy.

As a result of to the debate the Commission may be able to put forward appropriate legislative proposals.

Key terms used in the act
  • Eco-labelling: an eco-labelling scheme under which a product can bear a distinctive logo or statement by which consumers are assured that the product in question has been produced according to a given set of environmental standards.

Related Acts

Communication from the Commission to the Council and the European Parliament of 16 December 1997 – The future for the market in fisheries products in the European Union: responsibility, partnership and competitiveness [COM(1997) 719 final – Not published in the Official Journal].

Communication from the Commission of 28 May 2002 setting out a Community Action Plan to integrate environmental protection requirements into the Common Fisheries Policy [COM(2002) 186 final – Not published in the Official Journal].

Product energy consumption: Information and labelling

Product energy consumption: Information and labelling

Outline of the Community (European Union) legislation about Product energy consumption: Information and labelling

Topics

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

Energy > Energy efficiency

Product energy consumption: Information and labelling (from July 2011)

Document or Iniciative

Directive 2010/30/EU of the European Parliament and of the Council of 19 May 2010 on the indication by labelling and standard product information of the consumption of energy and other resources by energy-related products (Text with EEA relevance).

Summary

This Directive establishes a framework for labelling and consumer information regarding energy consumption for energy-related products *.

Which products are concerned?

The Directive shall apply to products which are likely to have a direct or indirect impact on the consumption of energy and on other potential resources during use. It does not apply to:

  • second-hand products;
  • any means of transport for persons or goods;
  • product rating plates.

What sort of information must be provided?

Suppliers shall place on the market products that have a label containing information on the product’s consumption of electric energy or other forms of energy.

Suppliers must also make available technical documentation including:

  • a general description of the product;
  • the results of design calculations carried out;
  • test reports;
  • the references allowing identification of similar models.

The technical documentation must be available for a period of five years.

Suppliers shall provide dealers with labels and product information free of charge.

Dealers must affix labels in such a way that they are visible and legible.

What are the conditions for distance selling?

In some situations, the final consumer does not see the product – in particular when purchasing by mail order, by catalogue or through the Internet. However, the consumer must have access to product information through delegated acts which specify the way in which the label or the fiche is displayed or provided to the end-user.

What is the function of delegated acts?

A delegated act shall indicate in particular:

  • a description of the product;
  • measurement standards and methods;
  • details of the technical documentation;
  • the design and content of the label. The classification of the product on the label shall be indicated using the letters A to G. The most efficient class shall be represented by A+++. A scale with a maximum of seven colours shall also be used, and dark green shall always represent the maximum level of efficiency;
  • the location where the label shall be fixed to the product;
  • the duration of label classification.

If a product is covered by a delegated act, contracting authorities which conclude public works, supply or service contracts as referred to in Directive 2004/18/EC shall procure products which comply with high performance levels, expressed as ‘energy classes’. These criteria are as follows:

  • products which allow significant energy savings to be made;
  • equivalent products on the market shall have a wide disparity in performance levels;
  • the Commission shall take into account relevant EU legislation and self-regulation.

A delegated act shall take into account environmental parameters.

The European Commission has the power to adopt delegated acts for a period of five years from 19 June 2010. The period shall be renewed automatically unless the European Parliament or the Council revoke this right. These two institutions also have the power to object to a delegated act.

Transitional provisions

Member States shall apply the provisions of the Directive from 20 July 2011. This Directive repeals Directive 92/75/EEC from 21 July 2011.

Key terms of the Act
  • Energy-related product: any good having an impact on energy consumption during use, which is placed on the market and/or put into service in the Union, including parts intended to be incorporated into energy-related products covered by this Directive which are placed on the market and/or put into service as individual parts for end-users and of which the environmental performance can be assessed independently.

Reference

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

Directive 2010/30/EU

19.6.2010

20.6.2011

OJ L 153 of 18.6.2010

Energy efficiency of office equipment: The Energy Star Programme

Energy efficiency of office equipment: The Energy Star Programme

Outline of the Community (European Union) legislation about Energy efficiency of office equipment: The Energy Star Programme

Topics

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

Energy > Energy efficiency

Energy efficiency of office equipment: The Energy Star Programme (EU – US)

Document or Iniciative

Council Decision 2006/1005/EC of 18 December 2006 concerning the conclusion of the Agreement between the Government of the United States of America and the European Community on the coordination of energy-efficiency labelling programmes for office equipment [Official Journal L 381 of 28.12.2006].

Agreement between the Government of the United States of America and the European Community on the coordination of energy-efficiency labelling programmes for office equipment [Official Journal L 381 of 28.12.2006].

Summary

The European Union (EU) and the United States of America (US) signed a new Energy Star * agreement on 28 December 2006, the aim of which is for manufacturers to voluntarily apply agreed specifications to measure the energy performance of office equipment.
The agreement was signed for a period of five years.

The “Energy Star”® label can be used for office equipment meeting these specifications, so that consumers can easily identify low-energy appliances. They are: computers, computer monitors, photocopiers, printers, digital duplicators, faxes, franking machines, multifunction devices and scanners.

The previous Energy Star agreement remains applicable only to computers until 31 December 2007 at the latest.
The new technical specifications for computers contain provisions on the active mode, unlike the previous agreement, which only took account of the standby mode.

Voluntary participation of manufacturers

Manufacturers, retailers and dealers of office equipment may join the Energy Star programme and use the “Energy Star® * ” label. Equipment labelled as such must meet the agreed specifications (Annex C) and may be tested by the manufacturer or by independent test laboratories.

Programme management and monitoring

The US and the EU each have a managing body for the programme: the US has the Environmental Protection Agency (EPA) and the EU has the European Community Energy Star Board (ECESB), set up in 2003 (see below under “Related Acts”).

The agreement sets out guidelines for the correct use of the Energy Star name and label.

The Commission – via the managing body – is responsible within the EU for testing office equipment carrying this label or checking that it meets the requirements.

If the product fails to meet the requirements, the ECESB:

  • notifies the manufacturer in writing that it fails to comply with the requirements;
  • drafts a plan to ensure compliance with the conditions in the programme;
  • if the conditions are not then met, cancels the manufacturer’s participation in the programme.

Amending and ending the agreement

Either the EU or the US may amend the programme of the managing bodies by common agreement. This includes amending technical specifications or including a new type of product if it becomes more energy efficient.

The agreement may also be ended by giving three months’ notice in writing to the other party. If the agreement is ended, the EU may no longer use the label “Energy Star®”.

Community decision-making

The Community decision-making process is used to establish the internal procedures needed to ensure the agreement operates smoothly.

This decision authorises the Commission to regularly adapt and reassess the technical specifications. The Commission is supported by a Community advisory committee made up of national representatives and all stakeholders.

Background

The first Energy Star agreement was signed with the US in 2001 for a 5-year period. This agreement renews the former agreement, with some changes made:

  • the technical specifications applicable to computer monitors, computers and imaging equipment were revised;
  • three obligations for the EU were removed: promotion of the Energy Star logo by the Commission and Member States, production by the ECESB of a report on market penetration of products meeting the criteria and information on the activities of the ECESB for the Commission to draw up and send to the European Parliament and the Council.
Key terms used in the act
  • Energy Star®: the registered service mark owned by the United States Environmental Protection Agency (EPA).
  • Energy Star labelling programme: a programme managed by a managing body using the specifications, marks and common guidelines on energy efficiency applicable to all designated product types.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Decision 2006/1005/EC 18.12.2006
18.12.2011
OJ L 381 of 28.12.2006

Related Acts

Commission Communication to the Council and the European Parliament on the implementation of the Energy Star programme in the Community for the period 2001-2005 [Official Journal L 381 of 28.12. 2007].

The communication states that the technical specifications contained in the previous agreement targeted the low power mode of office equipment on standby, when energy consumption of appliances in active mode is rising. Appliances are now more powerful and are kept in active mode for longer, due to the increasing use of Internet applications. The new agreement takes on board the importance of the active mode.

Commission Decision 2003/168/EC of 11 March 2003 establishing the European Community Energy Star Board [Official Journal L 67 of 12.03.2003].
This decision establishes the European Community Energy Star Board (ECESB) and includes a list of the national representatives in the Annex.
This board manages the Energy Star programme by regularly consulting Member States and manufacturers, national energy agencies and consumer organisations. The ECESB has also been involved in revising technical specifications.

Commission Decision 2003/367/EC of 15 May 2003 establishing the rules of procedure of the European Community Energy Star Board [Official Journal L 125 of 21.05.2003].

For more information on the Energy Star programme, please see the website set up by the Commission, which sets out the benefits of it for consumers, companies and the public sector.

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

Classification, packaging and labelling of dangerous preparations

Classification, packaging and labelling of dangerous preparations

Outline of the Community (European Union) legislation about Classification, packaging and labelling of dangerous preparations

Topics

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

Internal market > Single Market for Goods > Chemical products

Classification, packaging and labelling of dangerous preparations

Document or Iniciative

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [See amending acts].

Summary

Scope

This Directive applies to dangerous preparations which contain at least one dangerous substance within the meaning of Article 2 or which are considered dangerous within the meaning of Articles 5, 6 or 7. The term “preparation” covers mixtures or solutions composed of two or more substances.

This Directive provides specific provisions for preparations which are not considered dangerous (within the meaning of Articles 5, 6 or 7), but which may nevertheless present a specific hazard.

This Directive shall not apply to the following preparations in the finished state, intended for the final user:

  • medicinal products for human or veterinary use;
  • cosmetic products;
  • mixtures of substances in the form of waste covered by Directive 2006/12/EC on waste disposal);
  • foodstuffs;
  • animal feedingstuffs;
  • preparations containing radioactive substances;
  • medical devices which are invasive or used in direct physical contact with the human body;
  • the carriage of dangerous preparations by rail, road, inland waterway, sea or air;
  • ,preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing.

Classification

The classification of dangerous preparations shall be based on the definitions of categories of danger laid down in Article 2 of the Directive. These categories take into account the degree and specific nature of the hazards involved. They include preparations considered dangerous due to:

  • physico-chemical properties (for example, explosive, oxidising, or flammable); and/or
  • the health hazards it presents (for example, toxic, carcinogenic or harmful); and/or
  • the environmental hazards it presents.

The general principles of classification and labelling of dangerous substances applies to the methods specified in Regulation (EC) No 440/2008 and the criteria laid down in Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances, save where alternative criteria in the Directive are applied.

Packaging

The main requirements relating to packaging are as follows:

  • it shall be so designed and constructed that its contents cannot escape;
  • the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents;
  • packaging and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;
  • the shape and/or graphic decoration of packaging shall not arouse the curiosity of children nor mislead consumers;
  • it shall be designed so that it cannot be confused with foodstuffs, animal feedingstuffs, medicinal products or cosmetics;
  • containers for preparations must be fitted with child-resistant fastenings and/or carrying a tactile warning of danger.

Labelling

Any package must be clearly and indelibly marked with certain specific information such as:

  • the trade name of the preparation;
  • the name and contact details of the person responsible for placing it on the market;
  • in general the chemical name of the substance or substances present in the preparation which have given rise to the classification of the preparation with regard to health hazards;
  • the danger symbols and indications of danger, the risk phrases and the safety advice. Specific provisions concerning the presentation, format and wording of this information are laid down in Annexes II and VI to the Directive 67/548/EEC.

Member States may require the labelling of a preparation to be produced in their official language(s).

Under certain very restricted conditions specified in Article 12 of the Directive, some dangerous preparations may be exempt from the general requirements on packaging and labelling. Henceforth, the labelling of these preparations may be optional or may differ from the requirements laid down if the quantities present are so low that they do not present any hazard to users.

Obligations and duties of the Member States

The Member States appoint a national authority who shall inform the Commission on the application of this Directive. Those responsible for placing dangerous preparations on the market must hold at the disposal of that authority all information relating to the classification of the preparation (safety data, etc.).

Member States are required to designate the bodies responsible for receiving information on the health effects of preparations. This information can be used only in response to requests of a medical nature.

Confidentiality

The person responsible for placing a dangerous preparation on the market may make a request for confidentiality. This request is addressed to the competent authority of the Member States in which the preparation is to be first placed on the market. This procedure prevents the disclosure of the chemical identity of a certain substance on the label and does not risk the confidential nature of intellectual property. When the authority has made its decision, it shall inform the person responsible for placing the preparation on the market.

Free movement clause

Member States may not prohibit, restrict or impede the placing on the market of dangerous preparations which satisfy the requirements of this Directive.

Safeguard clause

A Member State may provisionally prohibit the placing on the market of a dangerous preparation or subject it to special conditions in its territory, even if it complies with the provisions of this Directive.

The Member States shall inform the Commission and the other Member States immediately of the adoption of such a measure and the reasons for its decision. The Commission shall consult Member States as soon as possible before making its decision.

Procedure for adaptation to technical progress

The amendments required to adapt the nine annexes to technical progress are adopted by the Commission with the assistance of a regulatory committee made up of representatives of the Member States and chaired by a representative of the Commission.

Context

This Directive shall be repealed with effect on 1 June 2015 by Regulation (EC) No 1272/2008 on the classification, labelling and packaging of chemicals and their mixtures.

References

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

Directive 1999/45/EC

30.7.1999

30.7.2002

O.J. L 200 of 30.7.1999

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

Regulation (EC) No 1907/2006

1.6.2007
Application:
1.6.2008
1.8.2008 (Art. 135)
1.6.2009 (Title VIII and Annex XVII)

OJ L 396 of 30.12.2006

Regulation (EC) No 1137/2008

11.12.2008

OJ L 311 of 21.11.2008

Regulation (EC) No 1272/2008

20.1.2009

OJ L 353 of 31.12.2008

The successive amendments and corrections to Directive 1999/45/EC have been incorporated in the original text. This consolidated version is of documentary value only.