CONTRIBUTION TO NOTIFICATION 2026/0351/ES (Notification 28222) - Directive (EU) 2015/1535 Draft Royal Decree developing the List of Domestic Companion Animal Species and the Positive List of Companion Animals Subject: barriers to trade in the internal market and legal uncertainty I submit this contribution as an interested person within the procedure for the provision of information on technical regulations under Directive (EU) 2015/1535. In my view, the notified Draft Royal Decree - and Law 7/2023 which it implements - constitute a barrier to trade in captive-bred companion animals, both through the restriction they impose and through the serious legal uncertainty they generate, and the reasons given in the notification message do not justify them. 1. THE MEASURE CLOSES THE SPANISH MARKET TO ANIMALS LAWFULLY TRADED IN THE UNION The Positive List of Companion Animals (LPAC) works as a market-access list: only listed species may be kept, bred or traded in Spain, and any non-listed species is prohibited (Article 10(11)). This prohibition reaches animals born and bred in captivity that are lawfully bred and sold in other Member States under Regulation (EC) No 338/97. It is therefore a measure having equivalent effect to a quantitative restriction on imports, contrary to Article 34 of the Treaty on the Functioning of the European Union (TFEU), and it fragments the internal market guaranteed by Article 26 TFEU. This is not a contestable reading: the Regulatory Impact Assessment itself acknowledges that "the rule has an impact on the economy in so far as it limits the trade in certain animal species for keeping as companion animals". 2. THE PROHIBITION DOES NOT DISTINGUISH BETWEEN THE WILD-CAUGHT ANIMAL AND THE CAPTIVE-BRED ONE Union law does distinguish between the two, and the Draft ignores this: - Article 12(2) of Directive 92/43/EEC (Habitats Directive) limits the prohibition of keeping, transport and sale to "specimens taken in the wild", not to captive-bred ones. - The Court of Justice, in Didier Vergy (C-149/94, judgment of 8 February 1996), held that the protection of the Wild Birds Directive does not extend to specimens bred in captivity. This is how the European Commission itself reads it in its guidance document on that Directive, whose section 1.3.2 states that "protection does not extend to specimens bred in captivity", citing that very case in a footnote. - Article 8(3) of Regulation (EC) No 338/97 expressly derogates from the commercial ban for animals born and bred in captivity with their documentation. - The Court of Justice, in Tridon (C-510/99), held that an absolute ban on trading captive-bred animals is disproportionate. The Draft, by contrast, prohibits alike on the basis of the species, without regard to the origin of the animal. Its recitals even state that an animal bred in captivity "is not a domestic animal, but merely habituated to human presence", which contradicts Article 465 of the Civil Code (as amended by Law 17/2021), which assimilates domesticated animals to domestic or companion animals. A decisive point must be added: Union law does not merely tolerate captive breeding - it treats it as the preferable alternative to taking animals from the wild. In Ligue royale belge pour la protection des oiseaux (C-10/96), the Court of Justice held that a Member State may not authorise the capture of protected species to stock fanciers' aviaries where breeding and reproduction in captivity are possible, even if not yet practicable. By prohibiting the breeding and trade of captive-bred animals, the Draft removes precisely the alternative that the Court identified as preferable for conservation, and shifts demand towards the only remaining source: capture from the wild. The effect runs counter to the biodiversity objective that the Impact Assessment itself declares. 3. THE REASONS GIVEN IN THE NOTIFICATION MESSAGE DO NOT WITHSTAND ANALYSIS - The CETS 125 Convention and its Article 4 do not authorise any list of species: Article 4 governs the welfare conditions of an animal already kept, not which species may be kept. The Convention defines a companion animal by its function, without lists. - The European Parliament Resolution of 24 November 2022 is not binding. Moreover, the EU Action Plan against Wildlife Trafficking (COM(2022) 581 final), to which that Resolution refers, confines any positive list to "specimens taken from the wild", confirming the very distinction that the Draft erases. - The claim that positive lists are better than negative ones is an opinion, not a technical fact. Several Member States use negative lists that are fully precautionary. - The control of illegal trafficking is already regulated by Regulation (EC) No 338/97 and, in Spain, by RD 7/2018. The list adds nothing to that control and instead prohibits captive-bred animals that those instruments permit. 4. THE INCLUSION CRITERIA ARE APPLIED WITHOUT WEIGHTING OR METHODOLOGY Market access depends on a species being placed on the LPAC, and that mechanism offers no predictability whatsoever. The Draft sets up two distinct routes to exclusion. Article 9.3 contains absolute bars ("in no case may they be listed"). Annex I is different: its twelve criteria "shall be assessed"; they do not exclude automatically. However, Article 12.4 provides that the opinion shall determine "whether any of them has been of an excluding nature". In other words: any one of the twelve criteria may become excluding on its own, without the Draft stating in which cases, at what threshold, or under what method. This indeterminacy is more burdensome for trade than an express prohibition. An automatic regime would be disproportionate but predictable. A regime in which any criterion may turn out to be excluding, with no rule governing that decision, allows nothing to be foreseen. And there is no weighting at all: no relative weight between criteria, no scoring system, no balance between risk and benefit, no account taken of mitigation measures. There is not a single quantified parameter in the whole of Annex I. Indeed, the version submitted to public consultation contained the only numerical threshold that existed - "in the case of mammals it shall be assessed that they do not exceed 5 kg, and for reptiles 2 kg" - and the version notified to the Commission has deleted it. An objectionable threshold has been replaced by unlimited discretion. Nor is any methodology imposed on the Scientific Committee, and the discretion is doubled: its opinion is non-binding (Article 10.4) and the decision rests with the Ministry (Article 10.5), likewise without any prescribed method, with deemed rejection by silence if it fails to decide (Article 10.6). To this is added a mutilated transposition of the precautionary principle. The Draft invokes Communication COM(2000) 1 final, point 6 of which requires measures to be proportional, NON-DISCRIMINATORY in their application, consistent, BASED ON AN EXAMINATION OF THE BENEFITS AND COSTS of action or lack of action, subject to review, and capable of assigning responsibility for producing the scientific evidence. Article 11.2 of the Draft replaces "non-discriminatory" with "non-discretionary" - removing precisely the safeguard that protects operators from other Member States - and omits entirely the examination of benefits and costs, that is, the only element that would require any weighing. The Draft deletes the mandate to weigh and then builds an assessment system without weighting. 5. A PARTICULARLY SERIOUS CRITERION: THE RD 570/2020 LIST USED AS A MARKET FILTER Criterion (k) of Annex I assesses whether the species is absent from the List of Royal Decree 570/2020. As explained above, it does not exclude automatically: it is an assessment criterion that the Committee may declare excluding under Article 12.4, without any rule determining when it should do so. That is precisely what makes it so damaging. RD 570/2020 is a rule for controlling the IMPORTATION of non-native species from third countries, enacted under the foreign-trade competence (Article 149.1.10 of the Constitution). The Royal Decree itself expressly acknowledges in its recitals that it "does not address the importation of specimens circulating freely within EU territory, but only that of species coming from third States". Any of those species may be freely brought into Spain from a German or Portuguese port, and RD 570/2020 admits it. It was never a barrier to internal trade. Moreover, appearing on that list does not even entail a ban on importing: it is enough for the risk analysis of the first application to be favourable for the species to be removed from the list and subsequent imports to be free. It is a case-by-case screening with assessment, not a veto. The Draft, by contrast, uses it as a ground for exclusion from the internal market without carrying out any risk assessment. The result is absurd: the budgerigar (Melopsittacus undulatus) - bred in captivity for over a century, not in any CITES Appendix or in the European list of invasive species - could be excluded from the LPAC for appearing on a list designed to control imports at ports and airports, even though it can be freely brought in from any other Member State. The same would apply to the chinchilla, the guppy or the Gouldian finch. The lack of objectivity is plain from one comparison: the domestic cat (Felis catus), accepted as a companion animal by the law itself and therefore exempt from any assessment, is listed among the world's hundred most damaging invasive alien species by the IUCN. The same logic of competition with native wildlife produces opposite results depending on whether the animal belongs to the three species the law accepts from the outset. 6. THOSE AFFECTED CANNOT REQUEST THE INCLUSION OF A SPECIES: THE PROCEDURE IS CLOSED TO THOSE WHO BEAR THE RESTRICTION This point deserves separate emphasis, because it directly contravenes the Andibel judgment. Andibel does not merely require objective criteria. It requires, as a self-standing condition, that THOSE AFFECTED BE ABLE TO APPLY for species to be added to the list, that the procedure be easily accessible, that it be completed within a reasonable time, and that a refusal be open to judicial challenge. That is the mechanism which prevents a positive list from becoming a permanent closure of the market. Article 10.1 of the Draft breaches this head-on. The inclusion or exclusion of a species "may be initiated ex officio or at the request of any public administration, animal protection entity or public or private association". The list is exhaustive, and it excludes precisely those who bear the restriction: THE PROFESSIONAL BREEDER, THE TRADE COMPANY, THE SPECIALIST VETERINARIAN AND THE PRIVATE KEEPER HAVE NO STANDING to request the inclusion of a species, not even by supplying the scientific evidence that would justify it. An operator in another Member State lawfully breeding and trading a species in the Union has no channel at all to seek access to the Spanish market: it is excluded with no means of its own to reverse that exclusion, and depends on a public administration, an animal protection entity or an association choosing to act on its behalf. The procedure is not "easily accessible" to those affected: it is simply not open to them. The restriction also runs counter to Spanish law itself, which confers the status of interested party on anyone holding a right or legitimate interest (Article 4 of Law 39/2015), and it empties the Andibel requirement of reviewability of any content: a person who cannot initiate the procedure obtains no refusal decision to challenge. Two further temporal barriers compound this exclusion. Applications are accepted only between 1 January and 1 March each year (Article 10.1). And after six months without a decision, the application is DEEMED REJECTED (Article 10.6); although Article 10.7 requires the decision to be reasoned, a deemed rejection by definition contains no reasons, which deprives any appeal of its subject matter. In addition, Article 10.2(d) requires the applicant to supply the scientific documentation demonstrating compliance with the criteria, reversing the burden of proof. The Dutch case-law developing Andibel (CBb, judgment of 4 May 2017, ECLI:NL:CBB:2017:70) annulled the Dutch positive list of mammals precisely because the weightings between criteria were not intelligible and because the burden of scientific justification lies with the administration, not the applicant. Taken together, this configures a market closed by default: no standing for those affected, a two-month annual window, deemed rejection, and no methodology disciplining the assessment. It is not a reviewable positive list: it is a barrier whose opening does not depend on those who suffer it. 7. THE RISKS INVOKED ARE ALREADY REGULATED BY THE UNION, AND NO ASSESSMENT IS PROVIDED The Impact Assessment declares three objectives - animal welfare, public health and safety and biodiversity, and control of keeping - acknowledges the impact on trade, and merely states that the obligations "are considered proportionate", without providing any risk assessment. Andibel (C-219/07) places the burden of demonstrating necessity and proportionality on the State; an assertion does not discharge it. Moreover, the risks invoked are already covered by European legislation that assesses species by species: - Invasive-species risk: Regulation (EU) No 1143/2014. - Sanitary and disease risk: Regulation (EU) 2016/429 (Animal Health Law). - Animal welfare: Article 13 TFEU and Article 4 of CETS 125. 8. THE GREATEST OBSTACLE IS LEGAL UNCERTAINTY: NO ONE CAN KNOW WHICH RULE APPLIES In Spain, each law must state expressly under which constitutional competence it is enacted; a competence that is not claimed is not deemed to have been exercised. Foreign trade belongs exclusively to the State under Article 149.1.10 of the Constitution, and it is by that route that Regulation (EC) No 338/97 is applied in Spain. Now, Article 32 of Law 7/2023 - which prohibits the keeping, breeding and trade of wild fauna in captivity - was NOT enacted under that Article 149.1.10 (the law reserved it solely to its Article 61). That is why Article 32 cannot prevent the breeding, sale or keeping of captive-bred animals that the European Regulation permits, and that is why the primacy of Union law is triggered: where a national rule conflicts with a directly applicable European regulation, the national rule must be disapplied (Costa v ENEL and Simmenthal). The Draft tries to fix this through the back door, by invoking Article 149.1.10 in its first final provision. But a regulation cannot claim a competence that its enabling law did not exercise (Article 9(3) of the Constitution; Article 128 of Law 39/2015). Added to this is the internal incoherence of the text, which calls the same animal "domestic", "wild" or "wild in captivity" depending on which article is applied. The definition of domestication in Article 3.2 takes the problem to the point of absurdity. It requires that the wild species has undergone a "significant alteration of its genotype and phenotype", giving rise to "a domestic species OR SUBSPECIES different from the wild species of origin"; and Article 6.1 requires every species, subspecies or breed on the LEDC to result from that process. The Draft thus makes the status of domestic animal depend on zoological nomenclature having recognised a taxon distinct from the wild one. Yet species universally recognised as domestic and bred in captivity for over a century have no differentiated domestic species or subspecies: the budgerigar (Melopsittacus undulatus) is a monotypic species with no described domestic taxon. Under Article 3.2 it could not demonstrate "domestication" and would fall outside the LEDC, despite being a domestic animal under the animal-health Law 8/2003 to which the Draft's own recitals refer. Excluded from the LEDC, Article 6.2(c) pushes it into the category of wild animal in captivity and, through Article 10(11), into prohibition. A trade barrier is thus created by a taxonomic requirement: a bird traded throughout the Union is kept out of the Spanish market not because of any risk, but because taxonomy has not assigned it a subspecific name. Article 9.3(d) deserves particular mention: placed within the clause listing species that "may not be entered on the LPAC", it nonetheless describes aquarium animals NOT included in catalogues of invasive or protected species. Read literally, harmless ornamental fish would be excluded from the LPAC and, by Article 10(11), prohibited. The entire aquarium sector cannot tell whether its market remains open or closed. The Draft also contains no mutual recognition clause safeguarding goods lawfully marketed in other Member States, as provided by Regulation (EU) 2019/515. For an operator in another Member State it is impossible to know whether an animal that is legal in the Union may be sold in Spain. That legal uncertainty is, in itself, a barrier to the internal market contrary to Article 26 TFEU. 9. FURTHERMORE, THE TEXT WAS NOTIFIED WITHOUT THE MANDATORY REPORTS The notified text has not completed its internal procedure: there is no record of the reports of the Autonomous Communities, of the ministries with economic and trade competence, of the Office for Regulatory Coordination and Quality, of the State Council for Animal Protection, or of the opinion of the Council of State that the Draft itself presupposes. The text is not final and may change substantially, and it is precisely the bodies that would have identified its impact on trade that have not reported. 10. I REQUEST That this contribution be communicated to the Spanish authorities so that: a) It be recognised that Article 32 of Law 7/2023 and its Royal Decree cannot restrict the keeping, breeding or trade of animals covered by Article 8(3) of Regulation (EC) No 338/97, for lack of competence over foreign trade and by reason of the primacy of Union law. b) The distinction between the wild-caught animal and the captive-bred one be recognised, in accordance with Article 12(2) of Directive 92/43/EEC, the Didier Vergy judgment - as read by the Commission's own guidance on the Birds Directive -, Article 8(3) of Regulation (EC) No 338/97 and the EU Action Plan against Wildlife Trafficking (COM(2022) 581 final); and that account be taken of Ligue royale belge (C-10/96), which treats captive breeding as the preferable alternative to taking animals from the wild. c) A regulated assessment methodology be established for the Annex I criteria - with thresholds, weighting between criteria and a balance between risk and benefit - and the power under Article 12.4 to declare any criterion excluding, with no rule governing that decision, be removed. d) The transposition of the precautionary principle be completed in accordance with point 6 of Communication COM(2000) 1 final, restoring the requirement that measures be non-discriminatory in their application and the examination of the benefits and costs of action and of lack of action. e) Criterion (k) of Annex I be deleted or reformulated, as it uses as a ground for exclusion a list controlling imports from third countries which its own rule acknowledges does not reach intra-EU circulation, and which is applied without the risk analysis that rule requires. f) The State be required to provide the risk assessment it asserts but does not supply, bearing in mind that those risks are already managed by Regulation (EU) 1143/2014, Regulation (EU) 2016/429 and the welfare obligations of Article 13 TFEU and CETS 125. g) The incoherence with the definition of wild fauna in Article 3.5 of Law 8/2003 and with Article 465 of the Civil Code be corrected, Article 9.3(d) on aquarium animals be clarified, and a mutual recognition clause be inserted in accordance with Regulation (EU) 2019/515. h) Standing to request the inclusion or exclusion of species be extended to ANY INTERESTED PARTY - breeders, trade companies, specialist veterinarians and private keepers, whether Spanish or from other Member States - currently excluded by the exhaustive list in Article 10.1; the two-month annual window be removed; the deemed rejection under Article 10.6 be replaced by an express, reasoned decision; and the burden of scientific justification be restored to the administration, currently reversed by Article 10.2(d). i) The definition of domestication in Article 3.2 be revised, since by requiring "a domestic species or subspecies different from the wild species of origin" it makes the status of domestic animal depend on the state of zoological nomenclature and would exclude from the LEDC companion species bred in captivity for over a century and traded throughout the Union, contrary to Law 8/2003 which the Draft's own recitals invoke. j) It be evidenced that the outstanding mandatory reports - in particular the opinion of the Council of State - have been issued, and the standstill period under Directive (EU) 2015/1535 be suspended until the unjustified restriction, the legal uncertainty and the procedural defect identified above have been remedied.