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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Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-7125

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

The 12/2013, 2 August, measures to improve the functioning of the food chain, law studies, reports and comparative analysis of prepared foodstuffs for sale to the final consumer, and whose results are intended for dissemination, must observe the principles of truthfulness, technical and analytical rigor and comply with all the guarantees referred to in national or Community rules in the field of analysis. Proper compliance with these principles, the fourth additional provision of Act 12/2013, August 2, expected to establish by regulation procedures on the taking of samples and analysis, and communication of results to those who will have to conform the studies, reports and comparative analysis.

The present Royal Decree aims at the fulfilment of this legal mandate, extending and updating the regulation of procedures and instruments used for the preparation of studies, reports and comparative analysis of food products ready for sale to the final consumer. Its scope of application will understand, therefore, to all them studies comparative destined to its publication or broadcasting for information to the consumer, excluding of its field them studies and projects technical developed with character scientific, that not is made with said object. The provisions of this Royal Decree shall not apply to studies, reports and comparative analysis initiated before its entry into force.

It is not only of extreme guarantees the accuracy of the publication of the results, but that also has to allow checking the veracity on the same samples taken for its realization, taking into account that it is food products that do not lend themselves to checking ex post if sufficient samples are not properly preserved to allow contrasting analysis.

On the other hand, in this Royal Decree are articulated mechanisms to preserve the confidentiality that must govern the realization of all the tests and analyses carried out in the framework of this procedure, including the identity of the laboratories where ones and others are carried out. Such confidentiality requires both to them laboratories as to the rest of them involved in the chain of custody of the newsletter of results and of them samples, i.e., to the personal of them laboratories and of the administrations public to which belong them two centers depositories of them samples.

In addition, to the activity carried out fulfilling all the requirements that are established here, may be useful for administrative actions of the competent authorities, in applying the principles of effectiveness of performances, efficiency and administrative economics.

He procedure established in the present Royal Decree not affects, or repeals, the mechanism official of takes of samples or the realization of tests expert analytical regulated, especially, in them articles 15 and 16 of the Real Decree 1945 / 1983, of 22 of June.

On the other hand, the Royal Decree 1716 / 2000, October 13, on health standards for intra-Community of animals of the bovine and porcine species Exchange, incorporated into our legal system Directive 97/12/EC of the Council of 17 March, by which amending and updating Directive 64/432/EEC, the Council, relating to animal health problems in intra of animals of the bovine and porcine species , the Directive 98/46/EC of the Council of 24 June, which amending Annexes A, D (chapter I) and F of Directive 64/432/EEC on animal health problems in the field of intra-Community trade of animals bovine and swine, Directive 98/99/EC, of the Council of 14 December 1998 , that modifies the cited Directive 97 / 12 / CE, and the Directive 2000 / 15 / CE, of the Parliament European and of the Council, of 10 of April, and 2000 / 20 / CE, of the Parliament European and of the Council, of 16 of mayo, both amending of the Directive 64 / 432 / EEC, of the Council, of 17 of March.

Directive 64/432/EEC, the Council, on 26 June, on to animal health problems in intra of animals of the bovine and porcine species, has been amended by Directive 2014/64/EU, of the European Parliament and of the Council, on May 15, 2014, amending Directive 64/432/EEC of the Council in regards to computerized databases that are part of networks of surveillance in them States members, to specify that the type of device of identification electronic, if is applied to them animals, must add is also to the list of elements that must contain them databases computerized, established in the cited directive.

Appropriate, therefore, its incorporation into our legal system by means of the corresponding amendment of article 12 of the Royal Decree 1716 / 2000 of 13 October. The necessary adaptation of the penalties law 8/2003, 24 April, from animal health is also attending.

Also, are available at the disposal end second, the extension of the period referred to in paragraph 1 of the transitional provision third, the Royal Decree 993/2014, 28 November, which establishes the procedure and the requirements of the veterinary official certification for export, which will allow that you can follow is proving the fulfilment of the requirements for the export of products of animal origin intended for drinking under previous regulations , until the 1 of March of 2016. Given the complexity of the tasks necessary to the adaptation of companies and management to the new provisions, the initially foreseen time has proved insufficient.

In the process of processing of this Royal Decree, have been consulted them communities autonomous and the entities representative of the sectors affected. The extension of the period laid down in the third transitional provision, section 1, of Royal Decree 993/2014, 28 November, has the favorable opinion of representatives of the sectors concerned and of the autonomous communities.

By virtue, on the proposal of the Minister of agriculture, food and the environment and the Minister of health, social services and equal, according to the Council of State and after deliberation by the Council of Ministers at its meeting of June 26, 2015, HAVE: CHAPTER I General provisions article 1. Object and scope of application.

1. object of this real Decree is regular them procedures e instruments used for the processing and communication of studies, reports and analysis comparative on products food willing for its sale to the consumer end, destined to its publication or broadcasting for information of the consumer.

2. is apply to all them studies, reports and analysis comparative, object of this standard, that is carried out on food, to know their features or determine the compliance of the legislation that les is of application or establish an analysis comparative between products of the same type offered in the market.

Excluded projects and technical or scientific studies that are not carried out in preparation for their publication or broadcast to inform the consumer, in particular publications in scientific journals, theses or books, developed with such character on any type of foodstuff, food, raw materials, intermediate or on its characteristics, evolution, conservation, packaging, product presentation and marketing.

Article 2. Definitions.

A_efectos_de referred to in this standard, shall be considered: to) maker of the study: any natural or legal person on whose initiative made the studies, reports and comparative analysis regulated in this standard.

(b) interested operator: the operator or operators responsible for the product whose name or business name and address is contained in the labelling.

Article 3. Factsheet.

1. the studies, reports and comparative analyses are subject to a sheet that makers of the study will be sent together with the results of the initial analysis to interested operators whose name and address appears on the labelling.

(2. those elements mandatory in the tab technical will be the following: to) object of the study.

(b) the type of product being studied.

(c) aspects and features that are being studied or comparing.

(d) method of sampling, as laid down in article 4.

(e) methods of analysis used, in accordance with article 5.

CHAPTER II article 4 sampling procedure. Method of sampling and buying products.

1. sampling will take place through the choice and purchase by the maker of the study, products will be evaluated, in settlements where they are marketed.


In the document that must be completed during the Act of sampling, as well as the identification of the establishment and the natural or legal person on behalf of whom the sampling, is made you will indicate the date of preparation of the sampling and, if applicable, that the same environmental conditions are normal conditions of marketing. Also, if necessary, shall contain information pertaining to special storage conditions indicated on the labelling of samples, in order to establish the strict observance of the same. Also, for better identification of the product is will make recorded the number of batch and it date of consumption preferential or, in your case, the date of expiration.

2. each sample will consist of three exemplary separated, belonging to the same lot whenever it is possible, that will be packed, sealed, identified and labelled so that, during the time of the custody and preservation of the same, to guarantee the identity of the samples with your content. The amount taken in each copy of sample is sufficient to perform the analytical determinations that they intend to carry out.

3. the producer of the Studio, respecting the conditions of conservation, will send one of the copies of sample laboratory designated to make the initial analysis at a time suitable to the nature of the object of the study product.

Under identical conditions, the other two copies will be sent, to the laboratory Arbitral agri-food of the Ministry of agriculture food and environment (MAGRAMA) or the center of research and Control of the quality of the Spanish Consumer Agency, food safety and nutrition (AECOSAN) of the Ministry of health, social services and equality, where will remain on deposit and will be maintained in perfect condition , so that, where appropriate, can be used in the realization of the casting and contradictory analyses, in the approved laboratories to participate in the official control of food designated by interested parties. The withdrawal of them exemplary in deposit is held always with the knowledge of the depositor of the same.

The ministries of agriculture, food and environment and health, social services and equality, as well as the laboratory and the Center will ensure full confidentiality of the data of the Bulletin of findings and of the origin of the samples when the maker of the study made use of its power to order confidentiality established in article 6.1.

Article 5. Methods of analysis and laboratories.

Methods of analysis shall be those used in the official control, which have been officially approved and, in default, the recommended national or internationally.

Laboratories involved in any of the analysis will have the same accreditation to the required to the approved laboratories to intervene in official food control.

Article 6. Communication of the results. Time limits and effects.

1. laboratory that perform the analysis initial will issue a bulletin of results, made according to their system of accreditation, in which shall contain the name and address of the laboratory. In addition, at the request of producer client of the study, will issue a report of findings, with identical content; it not shall contain the name and address of the laboratory, but it must be marked with a reference number which store correlation with the identification number of the Bulletin of results and, where appropriate, allow their traceability.

The performance report may be used as valid, by the maker of the study to inform the interested operator the results of the analysis. Additionally, makers of the study will send, in any case, a copy of the results report regulations to the depositary laboratory of the second and third issues of the sample.

Depositary laboratories and staff shall preserve the confidentiality of the information obtained, in particular with regard to the origin of the report's findings, still same perpetrators that their deposit activities do not affect the confidentiality of the information contained in the report of results, and may constitute breach of this obligation a serious or very serious violation for the purposes of the provisions of article 95 of the law 7/2007 April 12, the Basic Statute of the public employee, and without prejudice to the liability of the General Administration of the State for damage that breaking the chain of confidentiality of data could cause to the developers of the study or report.

The provisions of the preceding paragraph is understood without prejudice to the responsibility of laboratories and staff, as well as the sanction that is appropriate, in accordance with the legislation sanctioning power in the field of the protection of foodstuffs, where the breach of the chain of confidentiality occurs at the heart of the laboratory that performed the analysis.

2 once the initial analysis, the maker of the study, together with the sampling paper, communicated to the interested operator results, for his knowledge, with the following effects: a) in the event that there is no legal breach. In the case that the results of the initial analysis does not make clear a breach of the rules applicable in the matter, but the interested operator is not compatible with the results of the initial analysis, you can remove one of the copies of shows that were on deposit to perform analyses that deems appropriate, pursuant to the provisions of article 5. But such performances not interrupted the realization of the study or its publication, that, in all case, not is will produce before the term of fifteen days, counted from the date of notification of them results, by the producer of the study to the operator interested.

(b) in the case of legal non-compliance. When of the result of the analysis is derive a breach of the normative applicable in the matter, the operator interested, in a laboratory alien to the structure business of the same, may perform an analysis contradictory whose result must send to the producer of the study in the term of fifteen days, counted starting from the date of notification of them results, by the producer of the study to the operator interested. This period may be extended when the needs of analytical techniques to apply make it indispensable and justify it properly, what will have to be communicated to the producer of the report. The lack of response is regarded as the resignation of the interested operator to the contradictory analysis and acceptance of the results of the initial analysis.

In case of discrepancy between the results of both analyses, do not accept the second analysis, makers of the study will be a third analysis, with the third copy of sample, which will be casting.

All parties may be present, by itself or duly represented, at the time in that occurs for which casting analysis must be informed with sufficient notice, not less than seventy-two hours, by the laboratory that actually go to do it.

Without prejudice to the application of the preceding paragraphs, the procedure for both analysis and communication will be the one used in the official control of commercial quality of food.

When the interested operator is evidence enough of the existence of legal violations, it shall take the corrective measures without delay to remedy this situation and immediately communicated these facts to the competent authority.

3. notifications and communications to which becomes reference in this article is practiced by any means allowing them to be aware of them, as well as the date, identity and the content of the notification.

4. the costs incurred for the initial and contradictory analysis shall be borne by who to promote each of them. Those originated by the realization of the analysis casting will be to cargo of the part whose analysis have sense contrary to this.

5. the competent authority may use information relating to analytical results, for the purposes of official control and the eventual administrative proceedings that could be brought by the said authority.

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

Studies, reports and comparative analysis, as well as their summaries and synthesis, not induce error the consumer characteristics of food and in particular about the quality, nature, security or compliance with existing legislation.

The basic elements of the datasheet referred to in article 3 resulting from interest to consumers, in particular the type of product, and the aspects and features that will be studied, in addition when it is of interest, the bibliographic reference to the reports, studies and publications that support the evaluation criteria will be included in the publication.

First additional provision. No increase in public spending.

The application of the provisions of this Royal Decree does not imply increased public expenditure. The functions assumed, relating to the deposit and conservation of samples, will be carried out with the resources human and material resources allocated to the Ministry of agriculture, food and environment and the Ministry of health, social services and equality, and its dependent agencies.


Second additional provision. Non-application of the Royal Decree 1945 / 1983, of June 22.

It willing in the available additional first, paragraph 1, of the Real Decree 1945 / 1983, of 22 of June, by which is regulate them infringements and sanctions in matter of Defense of the consumer and of the production food, not is apply to them products food, which is governed by it established in this real Decree.

Available end first. Modification of the Royal Decree 1716 / 2000 of 13 October, on sanitary standards for intra-Community Exchange of animals of the bovine and porcine species.

He Real Decree 1716 / 2000, of 13 of October, about standards sanitary for the Exchange intra-Community of animals of the species bovine and swine, is modified as follows: one. Paragraph 1 of article 12 shall be amended in the following manner: to) the letter A) is modified as follows: 1 letter f) is replaced by the following: 'f) code or the unique identification code of the holding of birth.'

2nd added a new letter h), with the following content: «h) the type of identification e, if it is applied to the animal. "

((b) the letter C) is replaces by the following: «(C) for each exploitation, the name and address of the holder, and the code of identification of the same agreement with it willing in the Real Decree 479 / 2004, of 26 of March, by which is sets and regulates the register general of farms livestock.»

Two. Article 23 is replaced by the following: 'article 23. Regime sanctioning.

Breach of the provisions of this Royal Decree, it shall apply the regime of offences and penalties established in law 8/2003, of 24 April, animal health, without prejudice of potential liabilities civil, criminal or other that can compete.'

Second final provision. Modification of the third transitional provision of Royal Decree 993/2014, on 28 November, which establishes the procedure and the requirements of the official veterinary certification for export.

(1) of the third transitional provision of Royal Decree 993/2014, 28 November, which establishes the procedure and the requirements of the official veterinary certification for export, is replaced by the following: ' 1. Notwithstanding the provisions in article 8 and the repealing provision, until March 1, 2016» (, the accreditation of the compliance of them requirements required in each case for the export of products of origin animal destined to the consumption human is may perform before them services of inspection veterinary in border, of them following forms: to). with regard to the meat and products meat, in accordance with it planned to the effect in the order APA / 2555 / 2006, of 27 of July which establishes the procedure for the issuance of the official health certificate for export of meat and meat products, in matters of competence of the Ministry of agriculture, fisheries and food.

«(b) with regard to the rest of products, with the corresponding certifications of the community or communities autonomous competent in each case.»

Third final provision. Skill-related title.

This Royal Decree is issued under cover of the provisions of article 149.1.13. ª of the Spanish Constitution, which attributes to the State the exclusive competence in the field of bases and coordination of the general planning of economic activity.

By its part, them provisions late first and second of the real Decree is dictate of conformity with it planned in the article 149.1.16. ª of the Constitution Spanish, that attributed to the State the competition exclusive in matter of bases and coordination general of the health and in matter of health outside, respectively.

Available to finish fourth. Incorporation of Community law.

He joined the Spanish legal order the 2014/64/EU directive, the European Parliament and the Council, on May 15, 2014, amending Directive 64/432/EEC of the Council in regards to computerized databases that are part of the surveillance networks in the Member States by this Royal Decree.

Fifth final provision. Entry into force.

He present Royal Decree will enter in force the day following to the of your publication in the «Bulletin official of the State». However, the first final provision of the Royal Decree shall enter into force on the day, July 18, 2019.

Given in Madrid on 26 June 2015.

PHILIP R.

The Vice President of the Government and Minister of the Presidency, SORAYA SAENZ DE SANTAMARIA ANTON