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Draft Royal Decree on the indication of the origin of milk used as raw material on the labelling of milk and milk products
OFFICIAL STATE GAZETTE

Version 22/06/2017 modified
No 230 Saturday, 22 September 2018 Section I. p. 91664I

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004, is the legislation that harmonises the requirements for the provision of food information, in particular food labelling, within the European Union. It also lays down detailed rules concerning the indication of the country of origin or place of provenance.
GENERAL PROVISIONS

In accordance with the aforementioned Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011, indicating the country of origin of milk and of milk used as an ingredient in milk products on the labelling is, in principle, currently voluntary. This is because the Commission, after submitting the report to the European Parliament and the Council on the possibility of extending the mandatory labelling of the origin to also cover milk and milk used as an ingredient in milk products as referred to in Article 26(5)(b) and (c) of said regulation, has yet to adopt any legislation.
MINISTRY OF THE PRESIDENCY,

At the same time, the application of Article 26(3) of said Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011, relating to the country of origin or the place of provenance of the primary ingredient, is subject to the Commission adopting implementing acts, which have not yet been approved.
PARLIAMENTARY RELATIONS AND EQUALITY

Nevertheless, in accordance with the provisions of Article 26(2)(a) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011, indicating the origin shall be mandatory where failure to indicate this might mislead the consumer as to the true country of origin or place of provenance of the product.
Royal Decree 1181/2018 of 21 September 2018 on the indication of the origin of milk used as an ingredient on the labelling of milk and milk products.

On the other hand, Article 39 of the Regulation additionally enables the Member States to adopt national measures on the mandatory indication of the country of origin or place of provenance and lays down the requirements and procedures to be complied with.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004, is the legislation that harmonises the requirements for the provision of food information, in particular food labelling, within the European Union. It also lays down detailed rules concerning indication of the country of origin or place of provenance.

According to consumer habit surveys and public consultation, the origin of milk and milk products is certainly information of interest to the majority of consumers in Spain. In addition, this information generally tends to be perceived as a positive attribute associated with the quality of the product.
In accordance with aforementioned Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011, indicating the country of origin of milk and of milk used as an ingredient in milk products on the labelling is, in principle, currently voluntary. This is because the Commission, after submitting the report to the European Parliament and the Council on the possibility of extending the mandatory labelling of the origin to also cover milk and milk used as an ingredient in milk products as referred to in Article 26(5)(b and c) of said regulation, has yet to adopt any legislation.

Given the importance placed on labelling the origin of milk and milk products, it has been deemed appropriate to regulate this issue, on a test basis, for a period of two years, in line with similar regulations established in other neighbouring Member States. All this has the objective of providing more complete information on the origin of milk used as raw material to assist the consumer in their right to purchase choices.
Nevertheless, in accordance with the provisions of Article 26(2)(a) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011, indicating the origin shall be mandatory where failure to indicate this might mislead the consumer as to the true country of origin or place of provenance of the product.

The concept of a food's country of origin under Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 is determined in accordance with the rules of the European Union on non-preferential origin. These are currently regulated by Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code, which states that when more than one country or territory is involved in the production of a food, the food shall be deemed to originate in the country where it underwent its last, substantial processing or working, in an undertaking equipped for that purpose, resulting in the manufacture of a new product or representing an important stage of manufacture.
At the same time, Article 26(3) of said Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 states that if the country of origin or place of provenance of a food is indicated and is not the same as that of the primary ingredient, the label shall also indicate the country of origin or place of provenance of the primary ingredient in question, or shall indicate that it differs from that of the food. This requirement shall apply starting from 1 April 2020, the date of entry into force of recent Commission Implementing Regulation (EU) 2018/775 of 28 May 2018 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food.

However, the application of this concept to milk and milk products could lead to situations where milk has been obtained or processed in countries other than the final product's country of origin, in which case consumers would not be provided with sufficient information about the origin of the milk used.
On the other hand, moreover, Article 39 of cited Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 allows the Member States to introduce national measures for mandatory indication of the country of origin or place of provenance. The adoption of rules of this kind requires a demonstrated link between specific food qualities and the food origin or provenance. In addition, proof must be available that most consumers find it important to provide this information.

In this regard, surveys conducted on Spanish consumers have demonstrated to the European Commission that information on the origin of milk and milk products is in demand amongst the majority of consumers in Spain, who also associate an indication of the country of origin with the quality of the food.

This demonstrates that this Royal Decree meets the conditions set out in Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011.

Thus, given the importance placed on labelling the origin of milk and milk products, it has been deemed appropriate to regulate this, on a trial basis, for a period of two years, in line with similar regulations established in other neighbouring Member States. The objective of the above is to provide more complete information on the origin of milk used as raw material to assist consumers in their right to make purchasing choices.

The concept of a food’s country of origin under Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 is determined in accordance with the rules of the European Union on non-preferential origin. These are currently regulated by Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code, which states that when more than one country or territory is involved in the production of a food, the food shall be deemed to originate in the country where it underwent its last, substantial processing or working, in an undertaking equipped for that purpose, resulting in the manufacture of a new product or representing an important stage of manufacture.

However, application of this concept to milk and milk products could lead to situations where milk has been obtained or processed in countries other than the final product’s country of origin, in which case consumers would not be provided with sufficient information about the origin of the milk used.

Therefore, it would seem appropriate to adequately indicate the place of milking and the place where the milk was processed so as to further meet consumers' needs while at the same time avoiding complex labels and excessive burdens on companies, which would affect the final price of the product.

Regardless of the above, however, the criterion for the acquisition of the final product's country of origin is governed by the provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013.
Regardless of the above, however, the criterion for the acquisition of the final product’s country of origin is governed by the provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013.

On the other hand, given the commercial interest of the mandatory information that shall be provided pursuant to this royal decree, it would seem appropriate for food business operators to additionally be given the option of extending the mandatory indication of the milk's country of origin on the label with more precise information on the milk's place of provenance by indicating the name of a region or territory that the consumer may associate unequivocally with the milk's country of origin. This may be done provided that, for the same product type, the name of the region or territory does not match a name protected under Regulation (EU) No 1151/2012 of 21 November 2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs.
On the other hand, in addition to the mandatory information to be provided pursuant to this Royal Decree, food business operators have the option to add more specific information on the milk’s place of provenance by indicating the name of a region or territory that the consumer may associate unequivocally with the milk's country of origin. This may be done provided that, for the same product type, the name of the region or territory does not match a name protected under Regulation (EU) No 1151/2012 of 21 November 2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs.

In accordance with Article 39 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011, the purpose of this royal decree is to regulate the rules on the mandatory indication of the origin of milk used as raw material on the labelling of milk and milk products.
In accordance with Article 39 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011, the purpose of this Royal Decree is to regulate the rules on mandatory indication of the origin of milk used as an ingredient on the labelling of milk and milk products.

In drawing up this standard, the mandatory prior public consultation, hearing and public information procedures were complied with. The Autonomous Communities and the bodies representing the sectors concerned were also consulted, and the Interministerial Commission for Food Regulation (Comisión Interministerial para la Ordenación Alimentaria) issued a favourable report.
The drafting process for this statute completed the mandatory prior public consultation, hearing and public information procedures. The autonomous communities and the bodies representing the sectors concerned were also consulted, and the Interministerial Commission for Food Regulation (Comisión Interministerial para la Ordenación Alimentaria) issued a favourable report.

This provision has undergone the procedure of notification to the European Commission as provided for in Article 45 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011.
This provision has undergone the procedure for notification to the European Commission as provided for in Article 45 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011.

Additionally, in relation to the provisions on additional voluntary information in Article 5, this royal decree has undergone the procedure provided for in Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services.
Additionally, in relation to the provisions on additional voluntary information in Article 5, this Royal Decree has undergone the procedure provided for in Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services.

By virtue whereof, at the proposal of the Minister for Agriculture and Fisheries, Food and the Environment and the Minister for Health, Social Services and Equality, in accordance with the Council of State and following deliberation by the Council of Ministers at its meeting of ... …
The contents of this Royal Decree meet the principles for sound regulation set out in Article 129 of Law 39/2015 of 1 October 2015 on Common Administrative Procedures in Public Administration. Thus, in accordance with the principles of necessity and effectiveness, this statute is justified by the need to adopt an adequate framework for the dairy sector. This statute meets the principle of proportionality and is limited to the minimum required in order to apply European Union law. As per the principle of efficiency, administrative costs are limited to those strictly necessary to achieve the indicated objectives, within the framework of the European Union. As per the principle of transparency, and as part of the public hearing, the drafting process for this statute included consultations with the autonomous communities and entities representing the affected sectors, as well as consumers, through various means. Moreover, as per the principle of legal certainty, this initiative is consistent with prior legislation.

I HEREBY DECREE:
By virtue whereof, at the proposal of the Minister for Agriculture, Fisheries and Food and the Minister for Health, Consumer Affairs and Social Welfare, with the approval of Council of State and following deliberation of the Council of Ministers at its meeting of 21 September 2018,

Article 1. Purpose
I HEREBY DECREE THE FOLLOWING:

The purpose of this standard is to regulate the mandatory indication of the origin of milk used as raw material on the labelling of milk and milk products manufactured in Spain that are marketed in Spanish territory.
Article 1. Objective.

Article 2. Scope
The purpose of this statute is to regulate the mandatory indication of the origin of milk used as an ingredient on the labelling of milk and milk products produced in Spain and marketed in Spanish territory.

The provisions of this royal decree apply to the labelling of all types of milk and milk products listed in the annex and sold in pre-packaged form within the meaning of Article 2 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004.
Article 2. Scope.

However, by derogation from the previous paragraph, for those products in the annex that are regulated in Title II of Regulation (EU) No 1151/2012 of 21 November 2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs, the indication of the origin as laid down by this royal decree shall be voluntary.
1. The provisions of this Royal Decree apply to the labelling of all types of milk and milk products listed in the annex and sold in pre-packaged form pursuant to Article 2 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004.

In order to indicate the origin of milk used as raw material on the labelling of the products referred to in paragraph 1, the following provisions are laid down:
2. In order to indicate the origin of milk used as an ingredient on the labelling of the products referred to in paragraph 1, the following provisions are laid down:

a) Milk as a raw material is understood as that defined in Part III of Annex VII of Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007.
a) ‘milk’ shall have the meaning defined in Part III of Annex VII to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007;

b) It shall include milk from all species of animals for slaughter.
b) it shall include milk from all species of animals for slaughter;

c) The origin of the milk used as raw material representing a percentage higher than 50 %, by weight, in relation to the total volume of ingredients used shall be specified.
c) the origin of milk used as an ingredient in a percentage higher than 50 %, by weight, of the total ingredients used shall be indicated.

Article 3. Labelling. Indication of the origin of milk used as raw material on the labelling of milk and milk products
3. However, by derogation from the previous paragraph, for products in the annex that are regulated in Title II of Regulation (EU) No 1151/2012 of 21 November 2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs, indication of the origin as laid down by this Royal Decree shall be voluntary.

Milk and milk products referred to in Article 2(1), as listed in the annex, intended for the final consumer or mass caterers shall include on the label the following mandatory indications in relation to milk used as raw material:
Article 3. Labelling. Indication of the origin of milk used as an ingredient on the labelling of milk and milk products.

The name of the country in which the milking took place, through the expression: ‘País de ordeño: (nombre del país)’ [Country of milking: (name of country)]. For countries other than Spain, ‘(UE)’ [(EU)] or ‘(fuera de la UE)’ [(outside the EU)] may be indicated instead of a reference to the country.
1. Milk and milk products referred to in Article 2(1), as listed in the annex, intended for the end consumer or mass caterers shall include the following mandatory indications on the label regarding the milk used as an ingredient:

The name of the country in which the processing took place, through the expression: ‘País de transformación: (nombre del país)’ [Country of processing: (name of country)]’. For countries other than Spain, ‘(UE)’ or ‘(fuera de la UE)’ may be indicated instead of a reference to the country.
a) ‘País de ordeño: (lugar donde la leche ha sido ordeñada)’ [Country of milking: (place where the animals were milked)];

However, where several countries are involved in the milking or processing operations, the names of the countries may be replaced by one of the following: ‘UE’, ‘fuera de la UE’ or ‘UE y fuera de la UE’ [EU and outside the EU], as appropriate.
b) ‘País de transformación: (lugar donde la leche ha sido transformada)’ [Country of processing: (place where the milk was processed)];

If the two operations referred to in paragraph 1 take place in the same country, the indications referred to therein may be replaced by a single piece of information: ‘Origen de la leche: (nombre del país)’ [Milk origin: (name of country)]. However, if only one country is involved and this is not Spain, the following reference may be made: ‘Origen de la leche: (UE)’ [Milk origin: EU] or ‘Origen de la leche: (fuera de la UE)’ [Milk origin: outside the EU], as appropriate.
c) When milking and processing activities are performed in the same country, the indications in subparagraphs a and b may be replaced with: ‘Origen de la leche: (lugar donde la leche ha sido ordeñada y transformada)’ [Origin of the milk: (place where the animals were milked and the milk was processed)];

The references provided in paragraphs 1 and 2 shall be included in the list of ingredients immediately after the name of the ingredient in question, or in a note at the bottom of the list. They shall be displayed in the same size and font colour used for the list of ingredients.
d) The place of milking and the place of processing shall be indicated by a reference to the following geographic areas:

When the list of ingredients does not appear on the labelling, in accordance with Article 19(1)(d) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011, the information provided for in paragraphs 1 and 2 shall be displayed near the name of the food and will be printed with characters of the same size and font colour used for the name of the food.
1.º Member States(s) or third country/countries; or

The indications on the origin, as referred to in paragraphs 1 and 2, shall in no way be hidden, obscured or separated by any other written or pictorial matter or other element placed in between. They shall comply with the requirements in terms of availability and presentation of mandatory particulars laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011.
2.º ‘UE’ [EU] or ‘fuera de la UE’ [outside the EU] or ‘UE y fuera de la UE’ [EU and outside the EU]; or

Article 4. Traceability
3.º ‘España’ [Spain], provided that the country of milking or processing is Spain only, and cannot be replaced with ‘UE’ [EU].

Food business operators shall have adequate documentation, systems or procedures to demonstrate to the competent authority both the country of origin of milk used in the processing of milk and milk products included in the scope of this royal decree, and the conformity of the labelling of these products.
2. The indication referred to in paragraph 1 shall appear near the list of ingredients and in the same font size and colour used for the list of ingredients.

Article 5. Additional voluntary information
3. If the list of ingredients does not appear on the labelling, in accordance with Article 19(1)(d) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011, the information provided for in paragraph 1 shall be displayed near the name of the food and in the same font size and colour used for the name of the food.

Food business operators may add more precise information on the regional or territorial place of provenance of milk to the mandatory indications set out in Article 3, provided that the milk is sourced entirely from the specified origin and that the name of this region or territory does not match a name protected under Regulation (EU) No 1151/2012 of 21 November 2012 of the European Parliament and of the Council for the same type of product.
4. The indications of origin in paragraph 1 shall in no way be hidden, obscured or separated by any other written or pictorial matter or other element placed in between. They shall comply with the requirements in terms of availability and presentation of mandatory particulars laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011.

Article 4. Traceability.

Food business operators shall have adequate documentation, systems or procedures to demonstrate to the competent authority both the country of origin of milk used in the processing of milk and milk products included in the scope of this Royal Decree, and the conformity of the labelling of these products.

Article 5. Additional voluntary information.

Food business operators may add more precise information on the regional or territorial place of provenance of milk to the mandatory indications set out in Article 3, provided that the milk is sourced entirely from the indicated place of origin and that the name of this region or territory does not match a name protected under Regulation (EU) No 1151/2012 of 21 November 2012 of the European Parliament and of the Council for the same type of product.

The additional information referred to in the first subparagraph shall comply with the indications referred to in Article 3, and shall refer to the name of a region or territory that unequivocally belongs to the country of origin of the milk as shown on the label.

The above-mentioned additional information shall comply with the requirements applicable to voluntary food information in Chapter V of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011.
The aforementioned additional information shall comply with the requirements applicable to voluntary food information in Chapter V of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011.

Sole additional provision. Mutual recognition clause
Sole additional provision. Mutual recognition clause.

The requirements of this royal decree shall not apply to products lawfully manufactured or sold in other Member States of the European Union or to products from countries of the European Free Trade Association (EFTA), countries party to the Agreement on the European Economic Area (EEA) or countries that have a customs association agreement with the European Union.
The requirements of this Royal Decree shall not apply to products legally produced or marketed in other Member States of the European Union or third countries.

First transitional provision. Sale of product stocks
First transitional provision. Sale of product stocks.

Products manufactured or sold before the entry into force of this royal decree that satisfy the provisions applicable at the time may be sold until their stocks are exhausted.
Products manufactured before entry into force of this Royal Decree that meet the provisions applicable at the time may be marketed until their stocks are exhausted.

Second transitional provision. Duration of application
Second transitional provision. Duration of application.

The provisions of this royal decree shall apply for two years after entry into force.
The provisions of this Royal Decree shall apply for two years after entry into force.

However, if, before the end of this period, the European Commission adopts an implementing act within the meaning of Article 26 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 in relation to products referred to in the scope of this royal decree, the measure will cease to apply as of the date of entry into force of said European Commission act.
However, if, before the end of this period, the European Commission adopts an implementing act within the meaning of Article 26 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 in relation to mandatory labelling of the country of origin or place of provenance of products referred to in the scope of this Royal Decree, this measure shall cease to apply as at the date of entry into force of said European Commission act.

First final provision. Powers used
First final provision. Powers used.

This royal decree is laid down pursuant to subparagraphs 13 and 16 of Article 149(1) of the Spanish Constitution, which grant the State exclusive power regarding the principles and coordination of general economic planning, and the principles and coordination of health, respectively.
This Royal Decree is laid down pursuant to subparagraphs 13 and 16 under Article 149(1) of the Spanish Constitution, which grant the State exclusive power regarding the principles and coordination of general economic planning, and the principles and coordination of health, respectively.

Second final provision. Entry into force
Second final provision. Entry into force.

This royal decree shall enter into force on the day following four months after its publication.
This Royal Decree shall enter into force four months after its publication in the Official State Gazette.

Issued in Madrid, on 21 September 2018.

FELIPE R.

Vice President of the Government and Minister for the Presidency, Parliamentary Relations and Equality,

CARMEN CALVO POYATO

ANNEX

List of products referred to in Article 2(1)
List of products subject to the provisions of this Royal Decree

Combined nomenclature code (CN) Milk and milk products 0401 Milk and cream, not concentrated nor containing added sugar or other sweetening matter. 0402 Milk and cream, concentrated or containing added sugar or other sweetening matter. 0403 Buttermilk, curdled milk and cream, yoghurt, kephir and other fermented or acidified milk and cream, whether or not concentrated or containing added sugar or other sweetening matter or flavoured, or containing added fruit or cocoa. 0404 Whey, whether or not concentrated or containing added sugar or other sweetening matter; products consisting of natural milk constituents, whether or not containing added sugar or other sweetening matter, not elsewhere specified or included. 0405 Butter and other fats and oils derived from milk; dairy spreads. 0406 Cheese and curd.

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