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Royal Decree 538 / 2015, Of 26 Of June, By Which Is Regulates The Preparation Of Studies, Reports And Analysis Comparative On Products Food.

Original Language Title: Real Decreto 538/2015, de 26 de junio, por el que se regula la realización de estudios, informes y análisis comparativos sobre productos alimenticios.

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The Royal Decree 1945/1983 of 22 June on the regulation of infringements and sanctions in the field of consumer protection and agri-food production provides that in all the analyses carried out at the initiative of any natural or legal person whose results are intended for dissemination through the media, the same guarantees as those laid down for the analysis and the procedure of official control should apply.

Law 12/2013, of 2 August, of measures to improve the functioning of the food chain, provides that studies, reports and comparative analyses on food products arranged for sale to the final consumer, and the results of which are intended for dissemination, shall observe the principles of veracity, technical and analytical rigour and comply with all the guarantees referred to in the national or Community rules on analysis. For the correct implementation of these principles, the fourth provision of Law 12/2013, of 2 August, provides for the regulation of procedures on sampling and analysis, and on the communication of results to the Comparative studies, reports and analyses shall have to be adjusted.

This royal decree is intended to comply with this legal mandate, extending and updating the regulation of the procedures and instruments used for the preparation of comparative studies, reports and analyses. on foodstuffs prepared for sale to the final consumer. Its scope shall therefore include all comparative studies intended for publication or dissemination for information to the consumer, excluding from the scope of the studies and technical projects developed on a scientific basis, which are not carried out with that object. The provisions of this royal decree shall not apply to comparative studies, reports and analyses initiated before their entry into force.

It is not only about extreme guarantees about the veracity of the publication of the results obtained, but also that it must allow the verification of that veracity on the same samples taken for its realization, taking into account that these are foodstuffs which are not provided for ex-post verification if sufficient samples are not properly preserved to allow for contrasting analyses.

Moreover, in this royal decree, mechanisms are articulated to preserve the confidentiality that must preside over the conduct of all the tests and analyses carried out in the framework of this procedure, including the identity of the laboratories where some and others are carried out. This confidentiality obliges the laboratories and the other participants in the chain of custody of the results bulletin and of the samples, that is, the staff of the laboratories and the public administrations to which the belong to the two depository centres of the samples.

In addition, it is intended that the activity carried out in compliance with all the requirements set out here may be useful for the administrative actions of the competent authorities, in application of the principles of effectiveness of actions, efficiency and administrative economy.

The procedure laid down in this royal decree does not affect, either repeals, the official sampling mechanism or the carrying out of analytical expert tests, in particular in Articles 15 and 16 of the Royal Decree. Decree 1945/1983 of 22 June.

On the other hand, Royal Decree 1716/2000 of 13 October on sanitary rules for the intra-Community trade in bovine animals and swine, incorporated into our legal order Directive 97 /12/EC, of the Council of 17 March amending and updating Council Directive 64 /432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine, the Directive on the approximation of the laws of the Member States relating to 98 /46/EC of the Council of 24 June amending Annexes A, D (Chapter I) and F of the Directive 64 /432/EEC on animal health problems affecting the Community trade in bovine animals and swine, Council Directive 98 /99/EC of 14 December 1998 amending that Directive 97 /12/EC, and Directive 2000 /15/EC of the European Parliament and of the Council of 10 April and 2000 /20/EC of the European Parliament and of the Council of 16 May of 16 May of the two amendments to Council Directive 64 /432/EEC of 17 March.

Council Directive 64 /432/EEC of 26 June concerning animal health problems affecting intra-Community trade in bovine animals and swine has been amended by the Directive on the approximation of the laws of the Member States relating to: 2014 /64/EU of the European Parliament and of the Council of 15 May 2014 amending Council Directive 64 /432/EEC as regards the computerised databases forming part of the surveillance networks in the Member States, to specify that the type of electronic identification device, if applicable to the animals, it should also be added to the list of elements to be contained in the computerised databases set out in that Directive.

It is therefore appropriate to incorporate them into our legal order by amending Article 12 of Royal Decree 1716/2000 of 13 October. The necessary adaptation of the sanctioning regime to Law 8/2003 of 24 April of animal health is also addressed.

Furthermore, the extension of the time limit provided for in paragraph 1 of the third transitional provision, of Royal Decree 993/2014 of 28 November 2014, establishing the procedure and the procedure laid down in paragraph 1, is also available in the final provision. the requirements of the official veterinary certification for export, which shall enable it to be followed by certifying compliance with the requirements for the export of products of animal origin intended for human consumption in accordance with the previous legislation, until 1 March 2016. Given the complexity of the tasks required for the adaptation of the companies and the administration to the new forecasts, the period initially envisaged has been shown to be insufficient.

In the process of dealing with this royal decree, the autonomous communities and representative entities of the sectors affected have been consulted. The extension of the time limit provided for in the third paragraph of Article 1 of Royal Decree 993/2014 of 28 November 2014 appears to be in favour of the representatives of the sectors concerned and of the autonomous communities.

In its virtue, on the proposal of the Minister of Agriculture, Food and the Environment and the Minister of Health, Social Services and Equality, in agreement with the Council of State and after deliberation of the Council of Ministers in its Meeting of the day of June 26, 2015,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object and scope of application.

1. The purpose of this royal decree is to regulate the procedures and instruments used for the production and communication of studies, reports and comparative analyses on foodstuffs prepared for sale to the final consumer, intended for its publication or dissemination for consumer information.

2. It shall apply to all comparative studies, reports and analyses, which are the subject of this standard, to be carried out on food, in order to know its characteristics or to determine compliance with the legislation applicable to them or to establish a comparative analysis of products of the same type offered on the market.

Technical or scientific projects and studies that are not carried out for publication or dissemination are excluded to inform the consumer, in particular publications in scientific journals, theses or books, developed with such a character on any type of food, food, raw material, intermediate product or its characteristics, evolution, preservation, packaging, presentation or marketing.

Article 2. Definitions.

For the purposes of this rule, it shall be considered as:

(a) Study maker: any natural or legal person on whose initiative the studies, reports or comparative analyses covered by this standard are carried out.

b) Interested operator: the operator or operators responsible for the product whose name or social reason and address is listed on the label.

Article 3. Technical tab.

1. The comparative studies, reports and analyses shall be subject to a technical information sheet which the manufacturer of the study shall send together with the results of the initial analysis to the operators concerned whose name and address are on the label.

2. The mandatory elements in the technical sheet shall be as follows:

a) Object of the study.

b) The type of product being studied.

c) Aspects and features that are being studied or compared.

d) Method of sampling, as provided for in Article 4.

(e) Methods of analysis used, as provided for in Article 5.

CHAPTER II

Sample Take Procedure

Article 4. Method of sampling and purchasing of products.

1. Sampling shall be carried out by means of the choice and purchase by the study maker of the products to be evaluated, in the establishments where they are marketed.

In the document to be completed during the sampling act, in addition to the identification of the establishment and the natural or legal person on behalf of whom the sampling is carried out, the date of completion shall be indicated. sampling and, if appropriate, that the environmental conditions of the sampling are the normal marketing conditions. Also, where appropriate, the information corresponding to the special storage conditions indicated on the labelling of the samples shall be recorded in order to establish the strict observance of the samples. In addition, the batch number and the date of preferential consumption or, where applicable, the expiry date shall be recorded for the best identification of the product.

2. Each sample shall consist of three separate copies, belonging to the same batch where possible, which shall be conditioned, sealed, identified and labelled in such a way that, during the time of the custody and preservation thereof, ensure the identity of the samples with their contents. The quantity taken in each sample specimen shall be sufficient to make the analytical determinations to be carried out.

3. The manufacturer of the study, in compliance with the appropriate conservation conditions, shall send one of the sample samples to the laboratory designated to carry out the initial analysis at a time appropriate to the nature of the product concerned. study.

Under the same conditions, the other two copies will be sent to the Agri-Food Arbitration Laboratory of the Ministry of Food and Environment (MAGRAMA) or the Center for Research and Quality Control of the Spanish Agency for Consumption, Food Security and Nutrition (AECOSAN) of the Ministry of Health, Social Services and Equality, where they will remain in storage and remain in perfect state of conservation, so that, if necessary, they can be used in the carrying out the contradictory and diriment analyses, in the approved laboratories to participate in the official control of food designated by the interested parties. The removal of the specimens in deposit shall always be made with the knowledge of the depositor thereof.

The Ministries of Agriculture, Food and the Environment and Health, Social Services and Equality, as well as the Laboratory and the Centre will ensure the full confidentiality of the data in the results and source bulletin of the samples where the working party has made use of its power to request the confidentiality laid down in Article 6.1.

Article 5. Methods of analysis and laboratories.

The methods of analysis shall be those used in official control, which are officially approved and, in their absence, those recommended nationally or internationally.

The laboratories involved in any of the analyses shall have the same accreditation as required of the laboratories authorised to intervene in the official food control.

Article 6. Communication of the results. Deadlines and effects.

1. The laboratory carrying out the initial analysis shall issue a results bulletin, drawn up in accordance with its accreditation system, which shall include the name and address of the laboratory. In addition, at the request of the client of the study, a report of results shall be issued, with the same content; the name and address of the laboratory shall not be included in the report, but must be marked with a reference number with the identification number of the results bulletin and, where appropriate, allow its traceability.

The results report may be used, as a valid document, by the study maker to inform the interested operator of the results of the analysis. In addition, the study maker shall, in any case, send a copy of the results report to the depositary laboratory of the second and third sample specimens.

Depository laboratories and all their staff must preserve the confidentiality of the information obtained, in particular with regard to the origin of the report of results, being the same persons responsible for their activities as the deposit does not affect the confidentiality of the information contained in the results report, which may constitute a breach of this obligation a serious or very serious infringement for the purposes of Article 95 of Law 7/2007, of 12 April, of the Basic Staff Regulations, and without prejudice to liability assets of the General Administration of the State for damages that the breach of the data confidentiality chain could cause to the makers of the study or report.

The provisions of the foregoing paragraph are without prejudice to the responsibility of the laboratories and their personnel, as well as the sanction to be imposed, in accordance with the sanctioning rules in the field of protection of the food products, when the breakdown of the chain of confidentiality occurs within the laboratory that carried out the analysis.

2. Once the initial analysis has been carried out, the manufacturer of the study, together with the sampling document, shall inform the operator concerned of the results, for his/her knowledge, with the following effects:

a) In the event that there is no legal default. Where the results of the initial analysis do not reveal a non-compliance with the relevant legislation, but the operator concerned does not comply with the result of the initial analysis, it may withdraw one of the following: sample copies which were in storage to carry out the analyses which it considers appropriate, in accordance with Article 5. However, such actions shall not interrupt the conduct of the study or its publication, which shall not, in any event, be produced before the 15-day period, from the date of notification of the results, by the working party to the study. operator concerned.

b) In the case of legal non-compliance. Where the result of the analysis results in a failure to comply with the relevant rules, the operator concerned, in a laboratory outside the company's business structure, may carry out a contradictory analysis, the result of which must be submit to the study maker within a period of 15 days from the date of notification of the results by the study maker to the operator concerned. This period may be extended when the needs of the analytical techniques to be applied make it necessary and duly justified, which will have to be communicated to the working party of the report. Failure to respond shall be considered as the waiver of the operator concerned to perform the contradictory analysis and the acceptance of the results of the initial analysis.

In case of discrepancy between the results of the two analyses, if the second analysis is not accepted, the study maker will carry out a third analysis, with the third sample, which will be dirtier.

All parties may be present, by themselves or duly represented, at the time the analysis is carried out for which they shall be informed in good time, not less than seventy-two hours, by the laboratory that will effectively perform it.

Without prejudice to the application of the foregoing paragraphs, the procedure for the communication and performance of both analyses shall be that used in the official control of the commercial quality of food.

Where the operator concerned has sufficient evidence of the existence of legal non-compliance, it shall without delay take the corrective measures to remedy that situation and shall immediately communicate such facts to the competent authority.

3. The notifications and communications referred to in this Article shall be made by any means which permits their constancy, as well as the date, identity and content of the notification.

4. The costs incurred in carrying out the initial and contradictory analyses shall be borne by the person who promotes each of them. Those arising from the conduct of the analysis shall be carried out by the party whose analysis makes sense to the contrary.

5. The competent authority may use the information relating to the analytical results, for the purposes of official control and any administrative files which may be initiated by that authority.

Article 7. Publication of comparative studies, reports and analyses. Requirements.

Studies, reports and comparative analyses, as well as their summaries and summaries, shall not mislead the consumer as to the characteristics of the food and in particular the quality, nature, safety or compliance with existing legislation.

The publication shall include the basic elements of the technical information sheet referred to in Article 3 which are of interest to the consumer, in particular the type of product, and the aspects and characteristics of the product to study, in addition, the bibliographic reference to the reports, studies and publications that underpin the evaluation criteria.

Additional disposition first. No increase in public spending.

The application of the provisions of this royal decree will not imply an increase in public spending. The functions assumed, relating to the deposit and preservation of the samples, shall be carried out with the human resources and material means for the Ministry of Agriculture, Food and Environment and the Ministry of Health, Social Services e Equality, and its dependent bodies.

Additional provision second. Application of Royal Decree 1945/1983 of 22 June.

The provisions of the first paragraph of Article 1 (1) of Royal Decree 1945/1983 of 22 June 1983 governing infringements and penalties in respect of the defence of the consumer and of agri-food production apply to food products, which shall be governed by the provisions of this royal decree.

Final disposition first. Amendment of Royal Decree 1716/2000 of 13 October on sanitary rules for the intra-Community trade in bovine animals and swine.

Royal Decree 1716/2000 of 13 October on sanitary rules for the intra-Community trade in bovine animals and swine is hereby amended as follows:

One. Article 12 (1) is amended as follows:

(a) Point (A) is amended as follows:

1. º The letter f) is replaced by the following:

"(f) The unique identification code (s) of the holding of birth."

2. º A new letter is added (h), with the following content:

"h) The type of electronic identification means, if applicable to the animal."

(b) Point (C) is replaced by the following:

" C) For each holding, the name and address of the holder, and the identification code of the same agreement with the provisions of Royal Decree 479/2004 of 26 March, establishing and regulating the General Register of livestock holdings. '

Two. Article 23 is replaced by the following:

" Article 23. Sanctioning regime.

In the event of non-compliance with the provisions of this royal decree, the regime of infringements and penalties laid down in Law 8/2003 of 24 April of animal health shall apply, without prejudice to any possible liability. civil, criminal or other order that may be present. "

Final disposition second. Amendment of the third transitional provision of Royal Decree 993/2014 of 28 November 2014 laying down the procedure and requirements of the official veterinary certification for export.

Paragraph 1 of the third transitional provision of Royal Decree 993/2014 of 28 November 2014 laying down the procedure and the requirements of the official veterinary certification for export is replaced by the following: the following:

" 1. By way of derogation from Article 8 and in the derogation provision, until 1 March 2016, the accreditation of compliance with the requirements laid down in each case for the export of products of animal origin intended for human consumption may be made to the Veterinary Inspection Services at Frontera, in the following ways:

(a) With regard to meat and meat products, in accordance with the provisions laid down for that purpose in Order APA/2555/2006 of 27 July 2006 laying down the procedure for the issue of the official health certificate of export of meat and meat products, in matters falling within the competence of the Ministry of Agriculture, Fisheries and Food.

b) For other products, with corresponding community certifications or autonomous communities competent in each case. "

Final disposition third. Competence title.

This royal decree is dictated by the provisions of article 149.1.13. of the Spanish Constitution, which attributes to the State exclusive competence in the field of bases and coordination of the general planning of the activity. economic.

For their part, the final and second provisions of the royal decree are dictated in accordance with the provisions of article 149.1.16. of the Spanish Constitution, which attributes to the State exclusive competence in the field of General principles and coordination of health and external health, respectively.

Final disposition fourth. Incorporation of Community law.

By this royal decree, Directive 2014 /64/EU, of the European Parliament and of the Council of 15 May 2014 amending Council Directive 64 /432/EEC in respect of the Spanish legal order is incorporated into the Spanish legal order. (a) the computerised databases which form part of the surveillance networks in the Member States.

Final disposition fifth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette". However, the final disposition of the royal decree will enter into force on July 18, 2019.

Given in Madrid, on June 26, 2015.

FELIPE R.

The Vice President of the Government and Minister of the Presidency,

SORAYA SAENZ DE SANTAMARIA ANTON