REGULATION (EU) No 1151/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 21 November 2012
on quality schemes for agricultural products and foodstuffs
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) and the first paragraph of Article 118 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1)
The quality and diversity of the Union’s agricultural, fisheries and aquaculture production is one of its important strengths, giving a competitive advantage to the Union’s producers and making a major contribution to its living cultural and gastronomic heritage. This is due to the skills and determination of Union farmers and producers who have kept traditions alive while taking into account the developments of new production methods and material.
(2)
Citizens and consumers in the Union increasingly demand quality as well as traditional products. They are also concerned to maintain the diversity of the agricultural production in the Union. This generates a demand for agricultural products or foodstuffs with identifiable specific characteristics, in particular those linked to their geographical origin.
(3)
Producers can only continue to produce a diverse range of quality products if they are rewarded fairly for their effort. This requires that they are able to communicate to buyers and consumers the characteristics of their product under conditions of fair competition. It also requires them to be able to correctly identify their products on the marketplace.
(4)
Operating quality schemes for producers which reward them for their efforts to produce a diverse range of quality products can benefit the rural economy. This is particularly the case in less favoured areas, in mountain areas and in the most remote regions, where the farming sector accounts for a significant part of the economy and production costs are high. In this way quality schemes are able to contribute to and complement rural development policy as well as market and income support policies of the common agricultural policy (CAP). In particular, they may contribute to areas in which the farming sector is of greater economic importance and, especially, to disadvantaged areas.
(5)
The Europe 2020 policy priorities as set out in the Commission Communication entitled ‘Europe 2020: A strategy for smart, sustainable and inclusive growth’, include the aims of achieving a competitive economy based on knowledge and innovation and fostering a high-employment economy delivering social and territorial cohesion. Agricultural product quality policy should therefore provide producers with the right tools to better identify and promote those of their products that have specific characteristics while protecting those producers against unfair practices.
(6)
The set of complementary measures envisaged should respect the principles of subsidiarity and proportionality.
(7)
Agricultural product quality policy measures are laid down in Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine-based drinks and aromatized wine-product cocktails (4); Council Directive 2001/110/EC of 20 December 2001 relating to honey (5) and in particular in Article 2 thereof, Council Regulation (EC) No 247/2006 of 30 January 2006 laying down specific measures for agriculture in the outermost regions of the Union (6) and in particular in Article 14 thereof; Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed (7); Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (8); Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (9) and in particular in Part II, Title II, Chapter I, Section I and in Section Ia, Subsection I thereof; Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products (10); and Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks (11).
(8)
The labelling of agricultural products and foodstuffs should be subject to the general rules laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (12), and in particular the provisions aimed at preventing labelling that may confuse or mislead consumers.
(9)
The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on agricultural product quality policy identified the achievement of a greater overall coherence and consistency of agricultural product quality policy as a priority.
(10)
The geographical indications scheme for agricultural products and foodstuffs and the traditional specialities guaranteed scheme have certain common objectives and provisions.
(11)
The Union has for some time been pursuing an approach that aims to simplify the regulatory framework of the CAP. This approach should also be applied to regulations in the field of agricultural product quality policy, without, in so doing, calling into question the specific characteristics of those products.
(12)
Some regulations that form part of the agricultural product quality policy have been reviewed recently but are not yet fully implemented. As a result, they should not be included in this Regulation. However, they may be incorporated at a later stage, once the legislation has been fully implemented.
(13)
In the light of the aforementioned considerations, the following provisions should be amalgamated into a single legal framework comprising the new or updated provisions of Regulations (EC) No 509/2006 and (EC) No 510/2006 and those provisions of Regulations (EC) No 509/2006 and (EC) No 510/2006 that are maintained.
(14)
In the interests of clarity and transparency, Regulations (EC) No 509/2006 and (EC) No 510/2006 should therefore be repealed and replaced by this Regulation.
(15)
The scope of this Regulation should be limited to the agricultural products intended for human consumption listed in Annex I to the Treaty and to a list of products outside the scope of that Annex that are closely linked to agricultural production or to the rural economy.
(16)
The rules provided for in this Regulation should apply without affecting existing Union legislation on wines, aromatised wines, spirit drinks, product of organic farming, or outermost regions.
(17)
The scope for designations of origin and geographical indications should be limited to products for which an intrinsic link exists between product or foodstuff characteristics and geographical origin. The inclusion in the current scheme of only certain types of chocolate as confectionery products is an anomaly that should be corrected.
(18)
The specific objectives of protecting designations of origin and geographical indications are securing a fair return for farmers and producers for the qualities and characteristics of a given product, or of its mode of production, and providing clear information on products with specific characteristics linked to geographical origin, thereby enabling consumers to make more informed purchasing choices.
(19)
Ensuring uniform respect throughout the Union for the intellectual property rights related to names protected in the Union is a priority that can be achieved more effectively at Union level.
(20)
A Union framework that protects designations of origin and geographical indications by providing for their inclusion on a register facilitates the development of those instruments, since the resulting, more uniform, approach ensures fair competition between the producers of products bearing such indications and enhances the credibility of the products in the consumers’ eyes. Provision should be made for the development of designations of origin and geographical indications at Union level and for promoting the creation of mechanisms for their protection in third countries in the framework of the World Trade Organisation (WTO) or multilateral and bilateral agreements, thereby contributing to the recognition of the quality of products and of their model of production as a factor that adds value.
(21)
In the light of the experience gained from the implementation of Council Regulation (EEC) No 2081/92 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (13) and Regulation (EC) No 510/2006, there is a need to address certain issues, to clarify and simplify some rules and to streamline the procedures of this scheme.
(22)
In the light of existing practice, the two different instruments for identifying the link between the product and its geographical origin, namely the protected designation of origin and the protected geographical indication, should be further defined and maintained. Without changing the concept of those instruments, some modifications to the definitions should be adopted in order to better take into account the definition of geographical indications laid down in the Agreement on Trade-Related Aspects of Intellectual Property Rights and to make them simpler and clearer for operators to understand.
(23)
An agricultural product or foodstuff bearing such a geographical description should meet certain conditions set out in a specification, such as specific requirements aimed at protecting the natural resources or landscape of the production area or improving the welfare of farm animals.
(24)
To qualify for protection in the territories of Member States, designations of origin and geographical indications should be registered only at Union level. With effect from the date of application for such registration at Union level, Member States should be able to grant transitional protection at national level without affecting intra-Union or international trade. The protection afforded by this Regulation upon registration, should be equally available to designations of origin and geographical indications of third countries that meet the corresponding criteria and that are protected in their country of origin.
(25)
The registration procedure at Union level should enable any natural or legal person with a legitimate interest from a Member State, other than the Member State of the application, or from a third country, to exercise their rights by notifying their opposition.
(26)
Entry in the register of protected designations of origin and protected geographical indications should also provide information to consumers and to those involved in trade.
(27)
The Union negotiates international agreements, including those concerning the protection of designations of origin and geographical indications, with its trade partners. In order to facilitate the provision to the public of information about the names so protected, and in particular to ensure protection and control of the use to which those names are put, the names may be entered in the register of protected designations of origin and protected geographical indications. Unless specifically identified as designations of origin in such international agreements, the names should be entered in the register as protected geographical indications.
(28)
In view of their specific nature, special provisions concerning labelling should be adopted in respect of protected designations of origin and protected geographical indications that require producers to use the appropriate Union symbols or indications on packaging. In the case of Union names, the use of such symbols or indications should be made obligatory in order to make this category of products, and the guarantees attached to them, better known to consumers and in order to permit easier identification of these products on the market, thereby facilitating checks. Taking into account the requirements of the WTO, the use of such symbols or indications should be made voluntary for third-country geographical indications and designations of origin.
(29)
Protection should be granted to names included in the register with the aim of ensuring that they are used fairly and in order to prevent practices liable to mislead consumers. In addition, the means of ensuring that geographical indications and designations of origin are protected should be clarified, particularly as regards the role of producer groups and competent authorities of Member States.
(30)
Provision should be made for specific derogations that permit, for transitional periods, the use of a registered name alongside other names. Those derogations should be simplified and clarified. In certain cases, in order to overcome temporary difficulties and with the long-term objective of ensuring that all producers comply with the specifications, those derogations may be granted for a period of up to 10 years.
(31)
The scope of the protection granted under this Regulation should be clarified, in particular with regard to those limitations on registration of new trade marks set out in Directive 2008/95/EC of the European Parliament and of the Council of 22 October 2008 to approximate the laws of the Member States relating to trade marks (14) that conflict with the registration of protected designations of origin and protected geographical indications as is already the case for the registration of new trade marks at Union level. Such clarification is also necessary with regard to the holders of prior rights in intellectual property, in particular those concerning trade marks and homonymous names registered as protected designations of origin or as protected geographical indications.
(32)
Protection of designations of origin and geographical indications should be extended to the misuse, imitation and evocation of the registered names on goods as well as on services in order to ensure a high level of protection and to align that protection with that which applies to the wine sector. When protected designations of origin or protected geographical indications are used as ingredients, the Commission Communication entitled ‘Guidelines on the labelling of foodstuffs using protected designations of origin (PDOs) or protected geographical indications (PGIs) as ingredients’ should be taken into account.
(33)
The names already registered under Regulation (EC) No 510/2006 on 3 January 2013 should continue to be protected under this Regulation and they should be automatically included in the register.
(34)
The specific objective of the scheme for traditional specialities guaranteed is to help the producers of traditional products to communicate to consumers the value-adding attributes of their product. However, as only a few names have been registered, the current scheme for traditional specialities guaranteed has failed to realise its potential. Current provisions should therefore be improved, clarified and sharpened in order to make the scheme more understandable, operational and attractive to potential applicants.
(35)
The current scheme provides the option to register a name for identification purposes without reservation of the name in the Union. As this option has not been well understood by stakeholders and since the function of identifying traditional products can be better achieved at Member State or regional level in application of the principle of subsidiarity, this option should be discontinued. In the light of experience, the scheme should only deal with the reservation of names across the Union.
(36)
To ensure that names of genuine traditional products are registered under the scheme, the criteria and conditions for registration of a name should be adapted, in particular those concerning the definition of ‘traditional’, which should cover products that have been produced for a significant period of time.
(37)
To ensure that traditional specialities guaranteed comply with their specification and are consistent, producers organised into groups should themselves define the product in a specification. The option of registering a name as a traditional speciality guaranteed should be open to third-country producers.
(38)
To qualify for reservation, traditional specialities guaranteed should be registered at Union level. The entry in the register should also provide information to consumers and to those involved in the trade.
(39)
In order to avoid creating unfair conditions of competition, any producer, including a third-country producer, should be able to use a registered name of a traditional speciality guaranteed, provided that the product concerned complies with the requirements of the relevant specification and the producer is covered by a system of controls. For traditional specialities guaranteed produced within the Union, the Union symbol should be indicated on the labelling and it should be possible to associate it with the indication ‘traditional speciality guaranteed’.
(40)
In order to protect registered names from misuse, or from practices that might mislead consumers, their use should be reserved.
(41)
For those names already registered under Regulation (EC) No 509/2006 that, on 3 January 2013, would otherwise not be covered by the scope of this Regulation, the terms of use laid down in Regulation (EC) No 509/2006 should continue to apply for a transitional period.
(42)
A procedure should be introduced for registering names that are registered without reservation of name pursuant to Regulation (EC) No 509/2006, enabling them to be registered with reservation of name.
(43)
Provision should also be made for transitional measures applicable to registration applications received by the Commission before 3 January 2013.
(44)
A second tier of quality systems, based on quality terms which add value, which can be communicated on the internal market and which are to be applied voluntarily, should be introduced. Those optional quality terms should refer to specific horizontal characteristics, with regard to one or more categories of products, farming methods or processing attributes which apply in specific areas. The optional quality term ‘mountain product’ has met the conditions up to now and will add value to the product on the market. In order to facilitate the application of Directive 2000/13/EC where the labelling of foodstuffs may give rise to consumer confusion in relation to optional quality terms, including in particular ‘mountain products’, the Commission may adopt guidelines.
(45)
In order to provide mountain producers with an effective tool to better market their product and to reduce the actual risks of consumer confusion as to the mountain provenance of products in the market place, provision should be made for the definition at Union level of an optional quality term for mountain products. The definition of mountain areas should build on the general classification criteria employed to identify a mountain area in Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF) (15).
(46)
The added value of the geographical indications and traditional specialities guaranteed is based on consumer trust. It is only credible if accompanied by effective verification and controls. Those quality schemes should be subject to a monitoring system of official controls, in line with the principles set out in Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (16), and should include a system of checks at all stages of production, processing and distribution. In order to help Member States to better apply provisions of Regulation (EC) No 882/2004 for the controls of geographical indications and traditional specialities guaranteed, references to the most relevant articles should be mentioned in this Regulation.
(47)
To guarantee to the consumer the specific characteristics of geographical indications and traditional specialities guaranteed, operators should be subject to a system that verifies compliance with the product specification.
(48)
In order to ensure that they are impartial and effective, the competent authorities should meet a number of operational criteria. Provisions on delegating some competences of performing specific control tasks to control bodies should be envisaged.
(49)
European standards (EN standards) developed by the European Committee for Standardisation (CEN) and international standards developed by the International Organisation for Standardisation (ISO) should be used for the accreditation of the control bodies as well as by those bodies for their operations. The accreditation of those bodies should take place in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (17).
(50)
Information on control activities for geographical indications and traditional specialities guaranteed should be included in the multiannual national control plans and annual report prepared by the Member States in accordance with Regulation (EC) No 882/2004.
(51)
Member States should be authorised to charge a fee to cover the costs incurred.
(52)
Existing rules concerning the continued use of names that are generic should be clarified so that generic terms that are similar to or form part of a name or term that is protected or reserved should retain their generic status.
(53)
The date for establishing the seniority of a trade mark and of a designation of origin or a geographical indication should be that of the date of application of the trade mark for registration in the Union or in the Member States and the date of application for protection of a designation of origin or a geographical indication to the Commission.
(54)
The provisions dealing with the refusal or coexistence of a designation of origin or a geographical indication on the ground of conflict with a prior trade mark should continue to apply.
(55)
The criteria by which subsequent trade marks should be refused or, if registered, invalidated on the ground that they conflict with a prior designation of origin or geographical indication should correspond to the scope of protection of designation of origin or a geographical indication laid down.
(56)
The provisions of systems establishing intellectual property rights, and particularly of those established by the quality scheme for designations of origin and geographical indications or those established under trade mark law, should not be affected by the reservation of names and the establishment of indications and symbols pursuant to the quality schemes for traditional specialities guaranteed and for optional quality terms.
(57)
The role of groups should be clarified and recognised. Groups play an essential role in the application process for the registration of names of designations of origin and geographical indications and traditional specialities guaranteed, as well as in the amendment of specifications and cancellation requests. The group can also develop activities related to the surveillance of the enforcement of the protection of the registered names, the compliance of the production with the product specification, the information and promotion of the registered name as well as, in general, any activity aimed at improving the value of the registered names and effectiveness of the quality schemes. Moreover, it should monitor the position of the products on the market. Nevertheless, these activities should not facilitate nor lead to anti-competitive conduct incompatible with Articles 101 and 102 of the Treaty.
(58)
To ensure that registered names of designations of origin and geographical indications and traditional specialities guaranteed meet the conditions laid down by this Regulation, applications should be examined by the national authorities of the Member State concerned, in compliance with minimum common provisions, including a national opposition procedure. The Commission should subsequently scrutinise applications to ensure that there are no manifest errors and that Union law and the interests of stakeholders outside the Member State of application have been taken into account.
(59)
Registration as designations of origin, geographical indications and traditional specialities guaranteed should be open to names that relate to products originating in third countries and that satisfy the conditions laid down by this Regulation.
(60)
The symbols, indications and abbreviations identifying participation in a quality scheme, and the rights therein pertaining to the Union, should be protected in the Union as well as in third countries with the aim of ensuring that they are used on genuine products and that consumers are not misled as to the qualities of products. Furthermore, in order for the protection to be effective, the Commission should have recourse to reasonable budget resources on a centralised basis within the framework of Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (18) and in accordance with Article 5 of Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (19).
(61)
The registration procedure for protected designations of origin, protected geographical indications and traditional specialities guaranteed, including the scrutiny and the opposition periods, should be shortened and improved, in particular as regards decision making. The Commission, in certain circumstances acting with the assistance of Member States, should be responsible for decision-making on registration. Procedures should be laid down to allow the amendment of product specifications after registration and the cancellation of registered names, in particular if the product no longer complies with the corresponding product specification or if a name is no longer used in the market place.
(62)
In order to facilitate cross-border applications for joint registration of protected designations of origin, protected geographical indications or traditional specialities guaranteed, provision should be made for appropriate procedures.
(63)
In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of supplementing the list of products set out in Annex I to this Regulation; establishing the restrictions and derogations with regard to the sourcing of feed in the case of a designation of origin; establishing restrictions and derogations with regard to the slaughtering of live animals or with regard to the sourcing of raw materials; laying down rules which limit the information contained in the product specification; establishing the Union symbols; laying down additional transitional rules in order to protect the rights and legitimate interests of producers or stakeholders concerned; laying down further details on the eligibility criteria for the names of traditional specialities guaranteed; laying down detailed rules relating to the criteria for optional quality terms; reserving an additional optional quality term, laying down its conditions of use and amending those conditions; laying down derogations to the use of the term ‘mountain product’ and establishing the methods of production, and other criteria relevant for the application of that optional quality term, in particular, laying down the conditions under which raw materials or feedstuffs are permitted to come from outside the mountain areas; laying down additional rules for determining the generic status of terms in the Union; laying down rules for determining the use of the name of a plant variety or of an animal breed; defining the rules for carrying out the national objection procedure for joint applications concerning more than one national territory; and for complementing the rules of the application process, the opposition process, the amendment application process and the cancellation process in general. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(64)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards laying down rules on the form of the product specification; laying down detailed rules on the form and content of the register of protected designations of origin and protected geographical indications; defining the technical characteristics of the Union symbols and indications as well as the rules on their use on products, including the appropriate linguistic versions to be used; granting and extending transitional periods for temporary derogations for use of protected designations of origin and protected geographical indication; laying down detailed rules on the form and content of the register of traditional specialities guaranteed; laying down rules for the protection of traditional specialities guaranteed; laying down all measures relating to forms, procedures and other technical details for the application of Title IV; laying down rules for the use of optional quality terms; laying down rules for the uniform protection of indications, abbreviations and symbols referring to the quality schemes; laying down detailed rules on the procedure, form and presentation of applications for registration and of oppositions; rejecting the application; deciding on the registration of a name if an agreement has not been reached; laying down detailed rules on the procedure, form and presentation of an amendment application; cancelling the registration of a protected designation of origin, a protected geographical indication or a traditional speciality guaranteed; and laying down detailed rules on the procedure and form of the cancellation process and on the presentation of the requests for cancellation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (20).
(65)
In respect of establishing and maintaining registers of protected designations of origin, protected geographical indications and traditional specialties guaranteed, recognised under this scheme; defining the means by which the name and address of product certification bodies are to be made public; and registering a name if there is no notice of opposition or no admissible reasoned statement of opposition or in the case there is one the agreement has been reached, the Commission should be empowered to adopt implementing acts without applying Regulation (EU) No 182/2011,
HAVE ADOPTED THIS REGULATION:
TITLE I
GENERAL PROVISIONS
Article 1
Objectives
1. This Regulation aims to help producers of agricultural products and foodstuffs to communicate the product characteristics and farming attributes of those products and foodstuffs to buyers and consumers, thereby ensuring:
(a)
fair competition for farmers and producers of agricultural products and foodstuffs having value-adding characteristics and attributes;
(b)
the availability to consumers of reliable information pertaining to such products;
(c)
respect for intellectual property rights; and
(d)
the integrity of the internal market.
The measures set out in this Regulation are intended to support agricultural and processing activities and the farming systems associated with high quality products, thereby contributing to the achievement of rural development policy objectives.
2. This Regulation establishes quality schemes which provide the basis for the identification and, where appropriate, protection of names and terms that, in particular, indicate or describe agricultural products with:
(a)
value-adding characteristics; or
(b)
value-adding attributes as a result of the farming or processing methods used in their production, or of the place of their production or marketing.
Article 2
Scope
1. This Regulation covers agricultural products intended for human consumption listed in Annex I to the Treaty and other agricultural products and foodstuffs listed in Annex I to this Regulation.
In order to take into account international commitments or new production methods or material, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, supplementing the list of products set out in Annex I to this Regulation. Such products shall be closely linked to agricultural products or to the rural economy.
2. This Regulation shall not apply to spirit drinks, aromatised wines or grapevine products as defined in Annex XIb to Regulation (EC) No 1234/2007, with the exception of wine-vinegars.
3. This Regulation shall apply without prejudice to other specific Union provisions relating to the placing of products on the market and, in particular, to the single common organisation of the markets, and to food labelling.
4. Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (21) shall not apply to the quality schemes established by this Regulation.
Article 3
Definitions
For the purposes of this Regulation the following definitions shall apply:
(1)
‘quality schemes’ means the schemes established under Titles II, III and IV;
(2)
‘group’ means any association, irrespective of its legal form, mainly composed of producers or processors working with the same product;
(3)
‘traditional’ means proven usage on the domestic market for a period that allows transmission between generations; this period is to be at least 30 years;
(4)
‘labelling’ means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff;
(5)
‘specific character’ in relation to a product means the characteristic production attributes which distinguish a product clearly from other similar products of the same category;
(6)
‘generic terms ’ means the names of products which, although relating to the place, region or country where the product was originally produced or marketed, have become the common name of a product in the Union;
(7)
‘production step’ means production, processing or preparation;
(8)
‘processed products’ means foodstuffs resulting from the processing of unprocessed products. Processed products may contain ingredients that are necessary for their manufacture or to give them specific characteristics.
TITLE II
PROTECTED DESIGNATIONS OF ORIGIN AND PROTECTED GEOGRAPHICAL INDICATIONS
Article 4
Objective
A scheme for protected designations of origin and protected geographical indications is established in order to help producers of products linked to a geographical area by:
(a)
securing fair returns for the qualities of their products;
(b)
ensuring uniform protection of the names as an intellectual property right in the territory of the Union;
(c)
providing clear information on the value-adding attributes of the product to consumers.
Article 5
Requirements for designations of origin and geographical indications
1. For the purpose of this Regulation, ‘designation of origin’ is a name which identifies a product:
(a)
originating in a specific place, region or, in exceptional cases, a country;
(b)
whose quality or characteristics are essentially or exclusively due to a particular geographical environment with its inherent natural and human factors; and
(c)
the production steps of which all take place in the defined geographical area.
2. For the purpose of this Regulation, ‘geographical indication’ is a name which identifies a product:
(a)
originating in a specific place, region or country;
(b)
whose given quality, reputation or other characteristic is essentially attributable to its geographical origin; and
(c)
at least one of the production steps of which take place in the defined geographical area.
3. Notwithstanding paragraph 1, certain names shall be treated as designations of origin even though the raw materials for the products concerned come from a geographical area larger than, or different from, the defined geographical area, provided that:
(a)
the production area of the raw materials is defined;
(b)
special conditions for the production of the raw materials exist;
(c)
there are control arrangements to ensure that the conditions referred to in point (b) are adhered to; and
(d)
the designations of origin in question were recognised as designations of origin in the country of origin before 1 May 2004.
Only live animals, meat and milk may be considered as raw materials for the purposes of this paragraph.
4. In order to take into account the specific character of production of products of animal origin, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning restrictions and derogations with regard to the sourcing of feed in the case of a designation of origin.
In addition, in order to take into account the specific character of certain products or areas, the Commission shall be empowered to adopt delegated acts in accordance with Article 56, concerning restrictions and derogations with regard to the slaughtering of live animals or with regard to the sourcing of raw materials.
These restrictions and derogations shall, based on objective criteria, take into account quality or usage and recognised know-how or natural factors.
Article 6
Generic nature, conflicts with names of plant varieties and animal breeds, with homonyms and trade marks
1. Generic terms shall not be registered as protected designations of origin or protected geographical indications.
2. A name may not be registered as a designation of origin or geographical indication where it conflicts with a name of a plant variety or an animal breed and is likely to mislead the consumer as to the true origin of the product.
3. A name proposed for registration that is wholly or partially homonymous with a name already entered in the register established under Article 11 may not be registered unless there is sufficient distinction in practice between the conditions of local and traditional usage and presentation of the homonym registered subsequently and the name already entered in the register, taking into account the need to ensure equitable treatment of the producers concerned and that consumers are not misled.
A homonymous name which misleads the consumer into believing that products come from another territory shall not be registered even if the name is accurate as far as the actual territory, region or place of origin of the products in question is concerned.
4. A name proposed for registration as a designation of origin or geographical indication shall not be registered where, in the light of a trade mark’s reputation and renown and the length of time it has been used, registration of the name proposed as the designation of origin or geographical indication would be liable to mislead the consumer as to the true identity of the product.
Article 7
Product specification
1. A protected designation of origin or a protected geographical indication shall comply with a specification which shall include at least:
(a)
the name to be protected as a designation of origin or geographical indication, as it is used, whether in trade or in common language, and only in the languages which are or were historically used to describe the specific product in the defined geographical area;
(b)
a description of the product, including the raw materials, if appropriate, as well as the principal physical, chemical, microbiological or organoleptic characteristics of the product;
(c)
the definition of the geographical area delimited with regard to the link referred to in point (f)(i) or (ii) of this paragraph, and, where appropriate, details indicating compliance with the requirements of Article 5(3);
(d)
evidence that the product originates in the defined geographical area referred to in Article 5(1) or (2);
(e)
a description of the method of obtaining the product and, where appropriate, the authentic and unvarying local methods as well as information concerning packaging, if the applicant group so determines and gives sufficient product-specific justification as to why the packaging must take place in the defined geographical area to safeguard quality, to ensure the origin or to ensure control, taking into account Union law, in particular that on the free movement of goods and the free provision of services;
(f)
details establishing the following:
(i)
the link between the quality or characteristics of the product and the geographical environment referred to in Article 5(1); or
(ii)
where appropriate, the link between a given quality, the reputation or other characteristic of the product and the geographical origin referred to in Article 5(2);
(g)
the name and address of the authorities or, if available, the name and address of bodies verifying compliance with the provisions of the product specification pursuant to Article 37 and their specific tasks;
(h)
any specific labelling rule for the product in question.
2. In order to ensure that product specifications provide relevant and succinct information, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down rules which limit the information contained in the specification referred to in paragraph 1 of this Article, where such a limitation is necessary to avoid excessively voluminous applications for registration.
The Commission may adopt implementing acts laying down rules on the form of the specification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 8
Content of application for registration
1. An application for registration of a designation of origin or geographical indication pursuant to Article 49(2) or (5) shall include at least:
(a)
the name and address of the applicant group and of the authorities or, if available, bodies verifying compliance with the provisions of the product specification;
(b)
the product specification provided for in Article 7;
(c)
a single document setting out the following:
(i)
the main points of the product specification: the name, a description of the product, including, where appropriate, specific rules concerning packaging and labelling, and a concise definition of the geographical area;
(ii)
a description of the link between the product and the geographical environment or geographical origin referred to in Article 5(1) or (2), as the case may be, including, where appropriate, the specific elements of the product description or production method justifying the link.
An application as referred to in Article 49(5) shall, in addition, include proof that the name of the product is protected in its country of origin.
2. An application dossier referred to in Article 49(4) shall comprise:
(a)
the name and address of the applicant group;
(b)
the single document referred to in point (c) of paragraph 1 of this Article;
(c)
a declaration by the Member State that it considers that the application lodged by the applicant group and qualifying for the favourable decision meets the conditions of this Regulation and the provisions adopted pursuant thereto;
(d)
the publication reference of the product specification.
Article 9
Transitional national protection
A Member State may, on a transitional basis only, grant protection to a name under this Regulation at national level, with effect from the date on which an application is lodged with the Commission.
Such national protection shall cease on the date on which either a decision on registration under this Regulation is taken or the application is withdrawn.
Where a name is not registered under this Regulation, the consequences of such national protection shall be the sole responsibility of the Member State concerned.
The measures taken by Member States under the first paragraph shall produce effects at national level only, and they shall have no effect on intra-Union or international trade.
Article 10
Grounds for opposition
1. A reasoned statement of opposition as referred to in Article 51(2) shall be admissible only if it is received by the Commission within the time limit set out in that paragraph and if it:
(a)
shows that the conditions referred to in Article 5 and Article 7(1) are not complied with;
(b)
shows that the registration of the name proposed would be contrary to Article 6(2), (3) or (4);
(c)
shows that the registration of the name proposed would jeopardise the existence of an entirely or partly identical name or of a trade mark or the existence of products which have been legally on the market for at least five years preceding the date of the publication provided for in point (a) of Article 50(2); or
(d)
gives details from which it can be concluded that the name for which registration is requested is a generic term.
2. The grounds for opposition shall be assessed in relation to the territory of the Union.
Article 11
Register of protected designations of origin and protected geographical indications
1. The Commission shall adopt implementing acts, without applying the procedure referred to in Article 57(2), establishing and maintaining a publicly accessible updated register of protected designations of origin and protected geographical indications recognised under this scheme.
2. Geographical indications pertaining to products of third countries that are protected in the Union under an international agreement to which the Union is a contracting party may be entered in the register. Unless specifically identified in the said agreement as protected designations of origin under this Regulation, such names shall be entered in the register as protected geographical indications.
3. The Commission may adopt implementing acts laying down detailed rules on the form and content of the register. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
4. The Commission shall make public and regularly update the list of the international agreements referred to in paragraph 2 as well as the list of geographical indications protected under those agreements.
Article 12
Names, symbols and indications
1. Protected designations of origin and protected geographical indications may be used by any operator marketing a product conforming to the corresponding specification.
2. Union symbols designed to publicise protected designations of origin and protected geographical indications shall be established.
3. In the case of products originating in the Union that are marketed under a protected designation of origin or a protected geographical indication registered in accordance with the procedures laid down in this Regulation, the Union symbols associated with them shall appear on the labelling. In addition, the registered name of the product should appear in the same field of vision. The indications ‘protected designation of origin’ or ‘protected geographical indication’ or the corresponding abbreviations ‘PDO’ or ‘PGI’ may appear on the labelling.
4. In addition, the following may also appear on the labelling: depictions of the geographical area of origin, as referred to in Article 5, and text, graphics or symbols referring to the Member State and/or region in which that geographical area of origin is located.
5. Without prejudice to Directive 2000/13/EC, the collective geographical marks referred to in Article 15 of Directive 2008/95/EC may be used on labels, together with the protected designation of origin or protected geographical indication.
6. In the case of products originating in third countries marketed under a name entered in the register, the indications referred to in paragraph 3 or the Union symbols associated with them may appear on the labelling.
7. In order to ensure that the appropriate information is communicated to the consumer, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, establishing the Union symbols.
The Commission may adopt implementing acts defining the technical characteristics of the Union symbols and indications as well as the rules of their use on the products marketed under a protected designation of origin or a protected geographical indication, including rules concerning the appropriate linguistic versions to be used. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 13
Protection
1. Registered names shall be protected against:
(a)
any direct or indirect commercial use of a registered name in respect of products not covered by the registration where those products are comparable to the products registered under that name or where using the name exploits the reputation of the protected name, including when those products are used as an ingredient;
(b)
any misuse, imitation or evocation, even if the true origin of the products or services is indicated or if the protected name is translated or accompanied by an expression such as ‘style’, ‘type’, ‘method’, ‘as produced in’, ‘imitation’ or similar, including when those products are used as an ingredient;
(c)
any other false or misleading indication as to the provenance, origin, nature or essential qualities of the product that is used on the inner or outer packaging, advertising material or documents relating to the product concerned, and the packing of the product in a container liable to convey a false impression as to its origin;
(d)
any other practice liable to mislead the consumer as to the true origin of the product.
Where a protected designation of origin or a protected geographical indication contains within it the name of a product which is considered to be generic, the use of that generic name shall not be considered to be contrary to points (a) or (b) of the first subparagraph.
2. Protected designations of origin and protected geographical indications shall not become generic.
3. Member States shall take appropriate administrative and judicial steps to prevent or stop the unlawful use of protected designations of origin and protected geographical indications, as referred to in paragraph 1, that are produced or marketed in that Member State.
To that end Member States shall designate the authorities that are responsible for taking these steps in accordance with procedures determined by each individual Member State.
These authorities shall offer adequate guarantees of objectivity and impartiality, and shall have at their disposal the qualified staff and resources necessary to carry out their functions.
Article 14
Relations between trade marks, designations of origin and geographical indications
1. Where a designation of origin or a geographical indication is registered under this Regulation, the registration of a trade mark the use of which would contravene Article 13(1) and which relates to a product of the same type shall be refused if the application for registration of the trade mark is submitted after the date of submission of the registration application in respect of the designation of origin or the geographical indication to the Commission.
Trade marks registered in breach of the first subparagraph shall be invalidated.
The provisions of this paragraph shall apply notwithstanding the provisions of Directive 2008/95/EC.
2. Without prejudice to Article 6(4), a trade mark the use of which contravenes Article 13(1) which has been applied for, registered, or established by use if that possibility is provided for by the legislation concerned, in good faith within the territory of the Union, before the date on which the application for protection of the designation of origin or geographical indication is submitted to the Commission, may continue to be used and renewed for that product notwithstanding the registration of a designation of origin or geographical indication, provided that no grounds for its invalidity or revocation exist under Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark (22) or under Directive 2008/95/EC. In such cases, the use of the protected designation of origin or protected geographical indication shall be permitted as well as use of the relevant trade marks.
Article 15
Transitional periods for use of protected designations of origin and protected geographical indications
1. Without prejudice to Article 14, the Commission may adopt implementing acts granting a transitional period of up to five years to enable products originating in a Member State or a third country the designation of which consists of or contains a name that contravenes Article 13(1) to continue to use the designation under which it was marketed on condition that an admissible statement of opposition under Article 49(3) or Article 51 shows that:
(a)
the registration of the name would jeopardise the existence of an entirely or partly identical name; or
(b)
such products have been legally marketed with that name in the territory concerned for at least five years preceding the date of the publication provided for point (a) of Article 50(2).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
2. Without prejudice to Article 14, the Commission may adopt implementing acts extending the transitional period mentioned in paragraph 1 of this Article to 15 years in duly justified cases where it is shown that:
(a)
the designation referred to in paragraph 1 of this Article has been in legal use consistently and fairly for at least 25 years before the application for registration was submitted to the Commission;
(b)
the purpose of using the designation referred to in paragraph 1 of this Article has not, at any time, been to profit from the reputation of the registered name and it is shown that the consumer has not been nor could have been misled as to the true origin of the product.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
3. When using a designation referred to in paragraphs 1 and 2, the indication of country of origin shall clearly and visibly appear on the labelling.
4. To overcome temporary difficulties with the long-term objective of ensuring that all producers in the area concerned comply with the specification, a Member State may grant a transitional period of up to 10 years, with effect from the date on which the application is lodged with the Commission, on condition that the operators concerned have legally marketed the products in question, using the names concerned continuously for at least the five years prior to the lodging of the application to the authorities of the Member State and have made that point in the national opposition procedure referred to in Article 49(3).
The first subparagraph shall apply mutatis mutandis to a protected geographical indication or protected designation of origin referring to a geographical area situated in a third country, with the exception of the opposition procedure.
Such transitional periods shall be indicated in the application dossier referred to in Article 8(2).
Article 16
Transitional provisions
1. Names entered in the register provided for in Article 7(6) of Regulation (EC) No 510/2006 shall automatically be entered in the register referred to in Article 11 of this Regulation. The corresponding specifications shall be deemed to be the specifications referred to in Article 7 of this Regulation. Any specific transitional provisions associated with such registrations shall continue to apply.
2. In order to protect the rights and legitimate interests of producers or stakeholders concerned, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning additional transitional rules.
3. This Regulation shall apply without prejudice to any right of coexistence recognised under Regulation (EC) No 510/2006 in respect of designations of origin and geographical indications, on the one hand, and trade marks, on the other.
TITLE III
TRADITIONAL SPECIALITIES GUARANTEED
Article 17
Objective
A scheme for traditional specialities guaranteed is established to safeguard traditional methods of production and recipes by helping producers of traditional product in marketing and communicating the value-adding attributes of their traditional recipes and products to consumers.
Article 18
Criteria
1. A name shall be eligible for registration as a traditional speciality guaranteed where it describes a specific product or foodstuff that:
(a)
results from a mode of production, processing or composition corresponding to traditional practice for that product or foodstuff; or
(b)
is produced from raw materials or ingredients that are those traditionally used.
2. For a name to be registered as a traditional speciality guaranteed, it shall:
(a)
have been traditionally used to refer to the specific product; or
(b)
identify the traditional character or specific character of the product.
3. If it is demonstrated in the opposition procedure under Article 51 that the name is also used in another Member State or in a third country, in order to distinguish comparable products or products that share an identical or similar name, the decision on registration taken in accordance with Article 52(3) may provide that the name of the traditional speciality guaranteed is to be accompanied by the claim ‘made following the tradition of’ immediately followed by the name of a country or a region thereof.
4. A name may not be registered if it refers only to claims of a general nature used for a set of products, or to claims provided for by particular Union legislation.
5. In order to ensure the smooth functioning of the scheme, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning further details of the eligibility criteria laid down in this Article.
Article 19
Product specification
1. A traditional speciality guaranteed shall comply with a specification which shall comprise:
(a)
the name proposed for registration, in the appropriate language versions;
(b)
a description of the product including its main physical, chemical, microbiological or organoleptic characteristics, showing the product’s specific character;
(c)
a description of the production method that the producers must follow, including, where appropriate, the nature and characteristics of the raw materials or ingredients used, and the method by which the product is prepared; and
(d)
the key elements establishing the product’s traditional character.
2. In order to ensure that product specifications provide relevant and succinct information, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down rules which limit the information contained in the specification referred to in paragraph 1 of this Article, where such a limitation is necessary to avoid excessively voluminous applications for registration.
The Commission may adopt implementing acts laying down rules on the form of the specification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 20
Content of application for registration
1. An application for registration of a name as a traditional speciality guaranteed referred to in Article 49(2) or (5) shall comprise:
(a)
the name and address of the applicant group;
(b)
the product specification as provided for in Article 19.
2. An application dossier referred to in Article 49(4) shall comprise:
(a)
the elements referred to in paragraph 1 of this Article; and
(b)
a declaration by the Member State that it considers that the application lodged by the group and qualifying for the favourable decision meets the conditions of this Regulation and the provisions adopted pursuant thereto.
Article 21
Grounds for opposition
1. A reasoned statement of opposition as referred to in Article 51(2) shall be admissible only if it is received by the Commission before expiry of the time limit and if it:
(a)
gives duly substantiated reasons why the proposed registration is incompatible with the terms of this Regulation; or
(b)
shows that use of the name is lawful, renowned and economically significant for similar agricultural products or foodstuffs.
2. The criteria referred to in point (b) of paragraph 1 shall be assessed in relation to the territory of the Union.
Article 22
Register of traditional specialities guaranteed
1. The Commission shall adopt implementing acts, without applying the procedure referred to in Article 57(2), establishing and maintaining a publicly accessible updated register of traditional specialties guaranteed recognised under this scheme.
2. The Commission may adopt implementing acts laying down detailed rules on the form and content of the register. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 23
Names, symbol and indication
1. A name registered as a traditional speciality guaranteed may be used by any operator marketing a product that conforms to the corresponding specification.
2. A Union symbol shall be established in order to publicise the traditional specialities guaranteed.
3. In the case of the products originating in the Union that are marketed under a traditional speciality guaranteed that is registered in accordance with this Regulation, the symbol referred to in paragraph 2 shall, without prejudice to paragraph 4, appear on the labelling. In addition, the name of the product should appear in the same field of vision. The indication ‘traditional speciality guaranteed’ or the corresponding abbreviation ‘TSG’ may also appear on the labelling.
The symbol shall be optional on the labelling of traditional specialities guaranteed which are produced outside the Union.
4. In order to ensure that the appropriate information is communicated to the consumer, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, establishing the Union symbol.
The Commission may adopt implementing acts defining the technical characteristics of the Union symbol and indication, as well as the rules of their use on the products bearing the name of a traditional speciality guaranteed, including as to the appropriate linguistic versions to be used. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 24
Restriction on use of registered names
1. Registered names shall be protected against any misuse, imitation or evocation, or against any other practice liable to mislead the consumer.
2. Member States shall ensure that sales descriptions used at national level do not give rise to confusion with names that are registered.
3. The Commission may adopt implementing acts laying down rules for the protection of traditional specialities guaranteed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 25
Transitional provisions
1. Names registered in accordance with Article 13(2) of Regulation (EC) No 509/2006 shall be automatically entered in the register referred to in Article 22 of this Regulation. The corresponding specifications shall be deemed to be the specifications referred to in Article 19 of this Regulation. Any specific transitional provisions associated with such registrations shall continue to apply.
2. Names registered in accordance with the requirements laid down in Article 13(1) of Regulation (EC) No 509/2006, including those registered pursuant to applications referred to in the second subparagraph of Article 58(1) of this Regulation, may continue to be used under the conditions provided for in Regulation (EC) No 509/2006 until 4 January 2023 unless Member States use the procedure set out in Article 26 of this Regulation.
3. In order to protect the rights and legitimate interests of producers or stakeholders concerned, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down additional transitional rules.
Article 26
Simplified procedure
1. At the request of a group, a Member State may submit, no later than 4 January 2016, to the Commission names of traditional specialities guaranteed that are registered in accordance with Article 13(1) of Regulation (EC) No 509/2006 and that comply with this Regulation.
Before submitting a name, the Member State shall initiate an opposition procedure as defined in Article 49(3) and (4).
If it is demonstrated in the course of this procedure that the name is also used in reference to comparable products or products that share an identical or similar name, the name may be complemented by a term identifying its traditional or specific character.
A group from a third country may submit such names to the Commission, either directly or through the authorities of the third country.
2. The Commission shall publish the names referred to in paragraph 1 together with the specifications for each such name in the Official Journal of the European Union within two months from reception.
3. Articles 51 and 52 shall apply.
4. Once the opposition procedure has finished, the Commission shall, where appropriate, adjust the entries in the register set out in Article 22. The corresponding specifications shall be deemed to be the specifications referred to in Article 19.
TITLE IV
OPTIONAL QUALITY TERMS
Article 27
Objective
A scheme for optional quality terms is established in order to facilitate the communication within the internal market of the value-adding characteristics or attributes of agricultural products by the producers thereof.
Article 28
National Rules
Member States may maintain national rules on optional quality terms which are not covered by this Regulation, provided that such rules comply with Union law.
Article 29
Optional quality terms
1. Optional quality terms shall satisfy the following criteria:
(a)
the term relates to a characteristic of one or more categories of products, or to a farming or processing attribute which applies in specific areas;
(b)
the use of the term adds value to the product as compared to products of a similar type; and
(c)
the term has a European dimension.
2. Optional quality terms that describe technical product qualities with the purpose of putting into effect compulsory marketing standards and are not intended to inform consumers about those product qualities shall be excluded from this scheme.
3. Optional quality terms shall exclude optional reserved terms which support and complement specific marketing standards determined on a sectoral or product category basis.
4. In order to take into account the specific character of certain sectors as well as consumer expectations, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down detailed rules relating to the criteria referred to in paragraph 1 of this Article.
5. The Commission may adopt implementing acts laying down all measures related to forms, procedures or other technical details, necessary for the application of this Title. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
6. When adopting delegated and implementing acts in accordance with paragraphs 4 and 5 of this Article, the Commission shall take account of any relevant international standards.
Article 30
Reservation and amendment
1. In order to take account of the expectations of consumers, developments in scientific and technical knowledge, the market situation, and developments in marketing standards and in international standards, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, reserving an additional optional quality term and laying down its conditions of use.
2. In duly justified cases and in order to take into account the appropriate use of the additional optional quality term, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down amendments to the conditions of use referred to in paragraph 1 of this Article.
Article 31
Mountain product
1. The term ‘mountain product’ is established as an optional quality term.
This term shall only be used to describe products intended for human consumption listed in Annex I to the Treaty in respect of which:
(a)
both the raw materials and the feedstuffs for farm animals come essentially from mountain areas;
(b)
in the case of processed products, the processing also takes place in mountain areas.
2. For the purposes of this Article, mountain areas within the Union are those delimited pursuant to Article 18(1) of Regulation (EC) No 1257/1999. For third-country products, mountain areas include areas officially designated as mountain areas by the third country or that meet criteria equivalent to those set out in Article 18(1) of Regulation (EC) No 1257/1999.
3. In duly justified cases and in order to take into account natural constraints affecting agricultural production in mountain areas, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down derogations from the conditions of use referred to in paragraph 1 of this Article. In particular, the Commission shall be empowered to adopt a delegated act laying down the conditions under which raw materials or feedstuffs are permitted to come from outside the mountain areas, the conditions under which the processing of products is permitted to take place outside of the mountain areas in a geographical area to be defined, and the definition of that geographical area.
4. In order to take into account natural constraints affecting agricultural production in mountain areas, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning the establishment of the methods of production, and other criteria relevant for the application of the optional quality term established in paragraph 1 of this Article.
Article 32
Product of island farming
No later than 4 January 2014 the Commission shall present a report to the European Parliament and to the Council on the case for a new term, ‘product of island farming’. The term may only be used to describe the products intended for human consumption that are listed in Annex I to the Treaty the raw materials of which come from islands. In addition, for the term to be applied to processed products, processing must also take place on islands in cases where this substantially affects the particular characteristics of the final product.
That report shall, if necessary, be accompanied by appropriate legislative proposals to reserve an optional quality term ‘product of island farming’.
Article 33
Restrictions on use
1. An optional quality term may only be used to describe products that comply with the corresponding conditions of use.
2. The Commission may adopt implementing acts laying down rules for the use of optional quality terms. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 34
Monitoring
Member States shall undertake checks, based on a risk analysis, to ensure compliance with the requirements of this Title and, in the event of breach, shall apply appropriate administrative penalties.
TITLE V
COMMON PROVISIONS
CHAPTER I
Official controls of protected designations of origin, protected geographical indications and traditional specialities guaranteed
Article 35
Scope
The provisions of this Chapter shall apply in respect of the quality schemes set out in Title II and Title III.
Article 36
Designation of competent authority
1. In accordance with Regulation (EC) No 882/2004, Member States shall designate the competent authority or authorities responsible for official controls carried out to verify compliance with the legal requirements related to the quality schemes established by this Regulation.
Procedures and requirements of Regulation (EC) No 882/2004 shall apply mutatis mutandis to the official controls carried out to verify compliance with the legal requirement related to the quality schemes for all products covered by Annex I to this Regulation.
2. The competent authorities referred to in paragraph 1 shall offer adequate guarantees of objectivity and impartiality, and shall have at their disposal the qualified staff and resources necessary to carry out their functions.
3. Official controls shall cover:
(a)
verification that a product complies with the corresponding product specification; and
(b)
monitoring of the use of registered names to describe product placed on the market, in conformity with Article 13 for names registered under Title II and in conformity with Article 24 for names registered under Title III.
Article 37
Verification of compliance with product specification
1. In respect of protected designations of origin, protected geographical indications and traditional specialities guaranteed that designate products originating within the Union, verification of compliance with the product specification, before placing the product on the market, shall be carried out by:
(a)
one or more of the competent authorities as referred to in Article 36 of this Regulation; and/or
(b)
one or more of the control bodies within the meaning of point (5) of Article 2 of Regulation (EC) No 882/2004 operating as a product certification body.
The costs of such verification of compliance with the specifications may be borne by the operators that are subject to those controls. The Member States may also contribute to these costs.
2. In respect of designations of origin, geographical indications and traditional specialities guaranteed that designate products originating in a third country, the verification of compliance with the specifications before placing the product on the market shall be carried out by:
(a)
one or more of the public authorities designated by the third country; and/or
(b)
one or more of the product certification bodies.
3. Member States shall make public the name and address of the authorities and bodies referred to paragraph 1 of this Article, and update that information periodically.
The Commission shall make public the name and address of the authorities and bodies referred to in paragraph 2 of this Article and update that information periodically.
4. The Commission may adopt implementing acts, without applying the procedure referred to in Article 57(2), defining the means by which the name and address of product certification bodies referred to in paragraphs 1 and 2 of this Article shall be made public.
Article 38
Surveillance of the use of the name in the market place
Member States shall inform the Commission of the names and addresses of the competent authorities referred to in Article 36. The Commission shall make public the names and addresses of those authorities.
Member States shall carry out checks, based on a risk analysis, to ensure compliance with the requirements of this Regulation and, in the event of breaches, Member States shall take all necessary measures.
Article 39
Delegation by competent authorities to control bodies
1. Competent authorities may delegate, in accordance with Article 5 of Regulation (EC) No 882/2004, specific tasks related to official controls of the quality schemes to one or more control bodies.
2. Such control bodies shall be accredited in accordance with European Standard EN 45011 or ISO/IEC Guide 65 (General requirements for bodies operating product certification systems).
3. Accreditation referred to in paragraph 2 of this Article may only be performed by:
(a)
a national accreditation body in the Union in accordance with the provisions of Regulation (EC) No 765/2008; or
(b)
an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum.
Article 40
Planning and reporting of control activities
1. Member States shall ensure that activities for the control of obligations under this Chapter are specifically included in a separate section within the multi-annual national control plans in accordance with Articles 41, 42 and 43 of Regulation (EC) No 882/2004.
2. The annual reports concerning the control of the obligations established by this Regulation shall include a separate section comprising the information laid down in Article 44 of Regulation (EC) No 882/2004.
CHAPTER II
Exceptions for certain prior uses
Article 41
Generic terms
1. Without prejudice to Article 13, this Regulation shall not affect the use of terms that are generic in the Union, even if the generic term is part of a name that is protected under a quality scheme.
2. To establish whether or not a term has become generic, account shall be taken of all relevant factors, in particular:
(a)
the existing situation in areas of consumption;
(b)
the relevant national or Union legal acts.
3. In order to fully protect the rights of interested parties, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down additional rules for determining the generic status of terms referred to in paragraph 1 of this Article.
Article 42
Plant varieties and animal breeds
1. This Regulation shall not prevent the placing on the market of products the labelling of which includes a name or term protected or reserved under a quality scheme described in Title II, Title III, or Title IV that contains or comprises the name of a plant variety or animal breed, provided that the following conditions are met:
(a)
the product in question comprises or is derived from the variety or breed indicated;
(b)
consumers are not misled;
(c)
the usage of the name of the variety or breed name constitutes fair competition;
(d)
the usage does not exploit the reputation of the protected term; and
(e)
in the case of the quality scheme described in Title II, production and marketing of the product had spread beyond its area of origin prior to the date of application for registration of the geographical indication.
2. In order to further clarify the extent of rights and freedoms of food business operators to use the name of a plant variety or of an animal breed referred to in paragraph 1 of this Article, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning rules for determining the use of such names.
Article 43
Relation to intellectual property
The quality schemes described in Titles III and IV shall apply without prejudice to Union rules or to those of Member States governing intellectual property, and in particular to those concerning designations of origin and geographical indications and trade marks, and rights granted under those rules.
CHAPTER III
Quality scheme indications and symbols and role of producers
Article 44
Protection of indications and symbols
1. Indications, abbreviations and symbols referring to the quality schemes may only be used in connection with products produced in conformity with the rules of the quality scheme to which they apply. This applies in particular to the following indications, abbreviations and symbols:
(a)
‘protected designation of origin’, ‘protected geographical indication’, ‘geographical indication’, ‘PDO’, ‘PGI’, and the associated symbols, as provided for in Title II;
(b)
‘traditional speciality guaranteed’, ‘TSG’, and the associated symbol, as provided for in Title III;
(c)
‘mountain product’, as provided for in Title IV.
2. In accordance with Article 5 of Regulation (EC) No 1290/2005, the European Agricultural Fund for Rural Development (EAFRD) may, on the initiative of the Commission or on its behalf, finance, on a centralised basis, administrative support concerning the development, preparatory work, monitoring, administrative and legal support, legal defence, registration fees, renewal fees, trade mark watching fees, litigation fees and any other related measure required to protect the use of the indications, abbreviations and symbols referring to the quality schemes from misuse, imitation, evocation or any other practice liable to mislead the consumer, within the Union and in third countries.
3. The Commission shall adopt implementing acts laying down rules for the uniform protection of the indications, abbreviations and symbols referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 45
Role of groups
1. Without prejudice to specific provisions on producer organisations and inter-branch organisations as laid down in Regulation (EC) No 1234/2007, a group is entitled to:
(a)
contribute to ensuring that the quality, reputation and authenticity of their products are guaranteed on the market by monitoring the use of the name in trade and, if necessary, by informing competent authorities as referred to in Article 36, or any other competent authority within the framework of Article 13(3);
(b)
take action to ensure adequate legal protection of the protected designation of origin or protected geographical indication and of the intellectual property rights that are directly connected with them;
(c)
develop information and promotion activities aiming at communicating the value-adding attributes of the product to consumers;
(d)
develop activities related to ensuring compliance of a product with its specification;
(e)
take action to improve the performance of the scheme, including developing economic expertise, carrying out economic analyses, disseminating economic information on the scheme and providing advice to producers;
(f)
take measures to enhance the value of products and, where necessary, take steps to prevent or counter any measures which are, or risk being, detrimental to the image of those products.
2. Member States may encourage the formation and functioning of groups on their territories by administrative means. Moreover, Member States shall communicate to the Commission the name and address of the groups referred to in point 2 of Article 3. The Commission shall make this information public.
Article 46
Right to use the schemes
1. Member States shall ensure that any operator complying with the rules of a quality scheme set out in Titles II and III is entitled to be covered by the verification of compliance established pursuant to Article 37.
2. Operators who prepare and store a product marketed under the traditional speciality guaranteed, protected designation of origin or protected geographical indication schemes or who place such products on the market shall also be subject to the controls laid down in Chapter I of this Title.
3. Member States shall ensure that operators willing to adhere to the rules of a quality scheme set out in Titles III and IV are able to do so and do not face obstacles to participation that are discriminatory or otherwise not objectively founded.
Article 47
Fees
Without prejudice to Regulation (EC) No 882/2004 and in particular the provisions of Chapter VI of Title II thereof, Member States may charge a fee to cover their costs of managing the quality schemes, including those incurred in processing applications, statements of opposition, applications for amendments and requests for cancellations provided for in this Regulation.
CHAPTER IV
Application and registration processes for designations of origin, geographical indications, and traditional specialities guaranteed
Article 48
Scope of application processes
The provisions of this Chapter shall apply in respect of the quality schemes set out in Title II and Title III.
Article 49
Application for registration of names
1. Applications for registration of names under the quality schemes referred to in Article 48 may only be submitted by groups who work with the products with the name to be registered. In the case of a ‘protected designations of origin’ or ‘protected geographical indications’ name that designates a trans-border geographical area or in the case of a ‘traditional specialities guaranteed’ name, several groups from different Member States or third countries may lodge a joint application for registration.
A single natural or legal person may be treated as a group where it is shown that both of the following conditions are fulfilled:
(a)
the person concerned is the only producer willing to submit an application;
(b)
with regard to protected designations of origin and protected geographical indications, the defined geographical area possesses characteristics which differ appreciably from those of neighbouring areas or the characteristics of the product are different from those produced in neighbouring areas.
2. Where the application under the scheme set out in Title II relates to a geographical area in a Member State, or where an application under the scheme set out in Title III is prepared by a group established in a Member State, the application shall be addressed to the authorities of that Member State.
The Member State shall scrutinise the application by appropriate means in order to check that it is justified and meets the conditions of the respective scheme.
3. As part of the scrutiny referred to in the second subparagraph of paragraph 2 of this Article, the Member State shall initiate a national opposition procedure that ensures adequate publication of the application and that provides for a reasonable period within which any natural or legal person having a legitimate interest and established or resident on its territory may lodge an opposition to the application.
The Member State shall examine the admissibility of oppositions received under the scheme set out in Title II in the light of the criteria referred to in Article 10(1), or the admissibility of oppositions received under the scheme set out in Title III in the light of the criteria referred to in Article 21(1).
4. If, after assessment of any opposition received, the Member State considers that the requirements of this Regulation are met, it may take a favourable decision and lodge an application dossier with the Commission. It shall in such case inform the Commission of admissible oppositions received from a natural or legal person that have legally marketed the products in question, using the names concerned continuously for at least five years preceding the date of the publication referred to in paragraph 3.
The Member State shall ensure that its favourable decision is made public and that any natural or legal person having a legitimate interest has an opportunity to appeal.
The Member State shall ensure that the version of the product specification on which its favourable decision is based, is published, and shall provide electronic access to the product specification.
With reference to protected designations of origin and protected geographical indications, the Member State shall also ensure adequate publication of the version of the product specification on which the Commission takes its decision pursuant to Article 50(2).
5. Where the application under the scheme set out in Title II relates to a geographical area in a third country, or where an application under the scheme set out in Title III is prepared by a group established in a third country, the application shall be lodged with the Commission, either directly or via the authorities of the third country concerned.
6. The documents referred to in this Article which are sent to the Commission shall be in one of the official languages of the Union.
7. In order to facilitate the application process, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, defining the rules for carrying out the national objection procedure for joint applications concerning more than one national territory and complementing the rules of the application process.
The Commission may adopt implementing acts laying down detailed rules on procedures, form and presentation of applications, including for applications concerning more than one national territory. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 50
Scrutiny by the Commission and publication for opposition
1. The Commission shall scrutinise by appropriate means any application that it receives pursuant to Article 49, in order to check that it is justified and that it meets the conditions of the respective scheme. This scrutiny should not exceed a period of six months. Where this period is exceeded, the Commission shall indicate in writing to the applicant the reasons for the delay.
The Commission shall, at least each month, make public the list of names for which registration applications have been submitted to it, as well as their date of submission.
2. Where, based on the scrutiny carried out pursuant to the first subparagraph of paragraph 1, the Commission considers that the conditions laid down in this Regulation are fulfilled, it shall publish in the Official Journal of the European Union:
(a)
for applications under the scheme set out in Title II, the single document and the reference to the publication of the product specification;
(b)
for applications under the scheme set out in Title III, the specification.
Article 51
Opposition procedure
1. Within three months from the date of publication in the Official Journal of the European Union, the authorities of a Member State or of a third country, or a natural or legal person having a legitimate interest and established in a third country may lodge a notice of opposition with the Commission.
Any natural or legal person having a legitimate interest, established or resident in a Member State other than that from which the application was submitted, may lodge a notice of opposition with the Member State in which it is established within a time limit permitting an opposition to be lodged pursuant to the first subparagraph.
A notice of opposition shall contain a declaration that the application might infringe the conditions laid down in this Regulation. A notice of opposition that does not contain this declaration is void.
The Commission shall forward the notice of opposition to the authority or body that lodged the application without delay.
2. If a notice of opposition is lodged with the Commission and is followed within two months by a reasoned statement of opposition, the Commission shall check the admissibility of this reasoned statement of opposition.
3. Within two months after the receipt of an admissible reasoned statement of opposition, the Commission shall invite the authority or person that lodged the opposition and the authority or body that lodged the application to engage in appropriate consultations for a reasonable period that shall not exceed three months.
The authority or person that lodged the opposition and the authority or body that lodged the application shall start such appropriate consultations without undue delay. They shall provide each other with the relevant information to assess whether the application for registration complies with the conditions of this Regulation. If no agreement is reached, this information shall also be provided to the Commission.
At any time during these three months, the Commission may, at the request of the applicant extend the deadline for the consultations by a maximum of three months.
4. Where, following the appropriate consultations referred to in paragraph 3 of this Article, the details published in accordance with Article 50(2) have been substantially amended, the Commission shall repeat the scrutiny referred to in Article 50.
5. The notice of opposition, the reasoned statement of opposition and the related documents which are sent to the Commission in accordance with paragraphs 1 to 4 of this Article shall be in one of the official languages of the Union.
6. In order to establish clear procedures and deadlines for opposition, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, complementing the rules of the opposition procedure.
The Commission may adopt implementing acts laying down detailed rules on procedures, form and presentation of the oppositions. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 52
Decision on registration
1. Where, on the basis of the information available to the Commission from the scrutiny carried out pursuant to the first subparagraph of Article 50(1), the Commission considers that the conditions for registration are not fulfilled, it shall adopt implementing acts rejecting the application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
2. If the Commission receives no notice of opposition or no admissible reasoned statement of opposition under Article 51, it shall adopt implementing acts, without applying the procedure referred to in Article 57(2), registering the name.
3. If the Commission receives an admissible reasoned statement of opposition, it shall, following the appropriate consultations referred to in Article 51(3), and taking into account the results thereof, either:
(a)
if an agreement has been reached, register the name by means of implementing acts adopted without applying the procedure referred to in Article 57(2), and, if necessary, amend the information published pursuant to Article 50(2) provided such amendments are not substantial; or
(b)
if an agreement has not been reached, adopt implementing acts deciding on the registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
4. Acts of registration and decisions on rejection shall be published in the Official Journal of the European Union.
Article 53
Amendment to a product specification
1. A group having a legitimate interest may apply for approval of an amendment to a product specification.
Applications shall describe and give reasons for the amendments requested.
2. Where the amendment involves one or more amendments to the specification that are not minor, the amendment application shall follow the procedure laid down in Articles 49 to 52.
However, if the proposed amendments are minor, the Commission shall approve or reject the application. In the event of the approval of amendments implying a modification of the elements referred to in Article 50(2), the Commission shall publish those elements in the Official Journal of the European Union.
For an amendment to be regarded as minor in the case of the quality scheme described in Title II, it shall not:
(a)
relate to the essential characteristics of the product;
(b)
alter the link referred to in point (f)(i) or (ii) of Article 7(1);
(c)
include a change to the name, or to any part of the name of the product;
(d)
affect the defined geographical area; or
(e)
represent an increase in restrictions on trade in the product or its raw materials.
For an amendment to be regarded as minor in the case of the quality scheme described in Title III, it shall not:
(a)
relate to the essential characteristics of the product;
(b)
introduce essential changes to the production method; or
(c)
include a change to the name, or to any part of the name of the product.
The scrutiny of the application shall focus on the proposed amendment.
3. In order to facilitate the administrative process of an amendment application, including where the amendment does not involve any change to the single document and where it concerns a temporary change in the specification resulting from the imposition of obligatory sanitary or phytosanitary measures by the public authorities, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, complementing the rules of the amendment application process.
The Commission may adopt implementing acts laying down detailed rules on procedures, form and presentation of an amendment application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
Article 54
Cancellation
1. The Commission may, on its own initiative or at the request of any natural or legal person having a legitimate interest, adopt implementing acts to cancel the registration of a protected designation of origin or of a protected geographical indication or of a traditional speciality guaranteed in the following cases:
(a)
where compliance with the conditions of the specification is not ensured;
(b)
where no product is placed on the market under the traditional speciality guaranteed, the protected designation of origin or the protected geographical indication for at least seven years.
The Commission may, at the request of the producers of product marketed under the registered name, cancel the corresponding registration.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
2. In order to ensure legal certainty that all parties have the opportunity to defend their rights and legitimate interests, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56 complementing the rules regarding the cancellation process.
The Commission may adopt implementing acts laying down detailed rules on procedures and form of the cancellation process, as well as on the presentation of the requests referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2).
TITLE VI
PROCEDURAL AND FINAL PROVISIONS
CHAPTER I
Local farming and direct sales
Article 55
Reporting on local farming and direct sales
No later than 4 January 2014 the Commission shall present a report to the European Parliament and to the Council on the case for a new local farming and direct sales labelling scheme to assist producers in marketing their produce locally. That report shall focus on the ability of the farmer to add value to his produce through the new label, and should take into account other criteria, such as the possibilities of reducing carbon emissions and waste through short production and distribution chains.
That report shall, if necessary, be accompanied by appropriate legislative proposals on the creation of a local farming and direct sales labelling scheme.
CHAPTER II
Procedural rules
Article 56
Exercise of the delegation
1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in the second subparagraph of Article 2(1), Article 5(4), the first subparagraph of Article 7(2), the first subparagraph of Article 12(5), Article 16(2), Article 18(5), the first subparagraph of Article 19(2), the first subparagraph of Article 23(4), Article 25(3), Article 29(4), Article 30, Article 31(3) and (4), Article 41(3), Article 42(2), the first subparagraph of Article 49(7), the first subparagraph of Article 51(6), the first subparagraph of Article 53(3) and the first subparagraph of Article 54(2) shall be conferred on the Commission for a period of five years from 3 January 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of power referred to in the second subparagraph of Article 2(1), Article 5(4), the first subparagraph of Article 7(2), the first subparagraph of Article 12(5), Article 16(2), Article 18(5), the first subparagraph of Article 19(2), the first subparagraph of Article 23(4), Article 25(3), Article 29(4), Article 30, Article 31(3) and (4), Article 41(3), Article 42(2), the first subparagraph of Article 49(7), the first subparagraph of Article 51(6), the first subparagraph of Article 53(3) and the first subparagraph of Article 54(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to the second subparagraph of Article 2(1), Article 5(4), the first subparagraph of Article 7(2), the first subparagraph of Article 12(5), Article 16(2), Article 18(5), the first subparagraph of Article 19(2), the first subparagraph of Article 23(4), Article 25(3), Article 29(4), Article 30, Article 31(3) and (4), Article 41(3), Article 42(2), the first subparagraph of Article 49(7), the first subparagraph of Article 51(6), the first subparagraph of Article 53(3) and the first subparagraph of Article 54(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 57
Committee procedure
1. The Commission shall be assisted by the Agricultural Product Quality Policy Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
CHAPTER III
Repeal and final provisions
Article 58
Repeal
1. Regulations (EC) No 509/2006 and (EC) No 510/2006 are hereby repealed.
However, Article 13 of Regulation (EC) No 509/2006 shall continue to apply in respect of applications concerning products falling outside the scope of Title III of this Regulation, received by the Commission prior to the date of entry into force of this Regulation.
2. References to the repealed Regulations shall be construed as references to this Regulation and be read in accordance with the correlation table in Annex II to this Regulation.
Article 59
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
However, Article 12(3) and Article 23(3) shall apply from 4 January 2016, without prejudice to products already placed on the market before that date.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 21 November 2012.