CHAPTER II

The Commission shall request third countries which intend to export animals and goods to the Union to provide the following accurate and up-to-date information on the general organisation and management of sanitary and phytosanitary control systems in their territory: any sanitary or phytosanitary rules adopted or proposed within their territory; risk-assessment procedures and factors taken into consideration for the assessment of risks and for the determination of the appropriate level of sanitary or phytosanitary protection; any control and inspection procedures and mechanisms, including, where relevant, on animals or goods arriving from other third countries; official certification mechanisms; where appropriate, any measures taken following recommendations provided for in the first paragraph of Article 122; where relevant, results of controls performed on animals and goods intended to be exported to the Union; and where relevant, information on changes made to the structure and functioning of control systems adopted to meet Union sanitary or phytosanitary requirements or recommendations provided for in the first paragraph of Article 122. The request for information referred to in paragraph 1 shall be proportionate, taking account of the nature of the animals and goods to be exported to the Union and of the specific situation in, and structure of, the third country. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the conditions to be respected by animals and goods entering the Union from third countries which are necessary to ensure that the animals and goods comply with the relevant requirements established by the rules referred to in Article 1(2), with the exception of points (d), (e), (g) and (h) of Article 1(2), or with requirements recognised to be at least equivalent thereto. The conditions laid down in the delegated acts referred to in paragraph 1 shall identify animals and goods by referring to their codes from the Combined Nomenclature and may include: the requirement that certain animals and goods shall only enter the Union from a third country or region of a third country which appears on a list drawn up by the Commission for that purpose; the requirement that consignments of certain animals and goods from third countries be dispatched from, and obtained or prepared in, establishments which comply with the relevant requirements referred to in paragraph 1 or with requirements recognised to be at least equivalent thereto; the requirement that consignments of certain animals and goods be accompanied by an official certificate, an official attestation, or by any other evidence that the consignments comply with the relevant requirements referred to in paragraph 1 or with requirements recognised to be at least equivalent thereto, including the results of the analysis performed by an accredited laboratory; the obligation to provide the evidence referred to in point (c) in accordance with a specific format; any other requirement necessary to ensure that certain animals and goods offer a level of protection of health and, as regards GMOs, also of the environment, equivalent to that ensured by the requirements referred to in paragraph 1. The Commission may, by means of implementing acts, lay down rules on the format and type of official certificates, official attestations, or evidence required in accordance with the rules provided for in point (c) of paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). The inclusion of a third country or region thereof in the list referred to in point (a) of Article 126(2) shall be made in accordance with paragraphs 2 and 3 of this Article. The Commission shall approve, by means of implementing acts, the request transmitted to it for the purpose referred to in paragraph 1 of this Article by the third country concerned, accompanied by appropriate evidence and guarantees that the animals and goods concerned from that third country comply with the relevant requirements referred to in Article 126(1) or with requirements equivalent thereto. Those implementing acts shall be adopted and updated in accordance with the examination procedure referred to in Article 145(2). The Commission shall decide on the request referred to in paragraph 2 taking into account, as appropriate: the third country’s legislation in the sector concerned; the structure and organisation of the competent authorities of the third country and its control services, the powers available to them, the guarantees that can be provided with regard to the application and enforcement of the legislation of the third country applicable to the sector concerned, and the reliability of the official certification procedures; the performance by the competent authorities of the third country of adequate official controls and other activities to assess the presence of hazards for human, animal or plant health, for animal welfare or, in relation to GMOs and plant protection products, also for the environment; the regularity and rapidity of information supplied by the third country on the presence of hazards for human, animal or plant health, for animal welfare or, in relation to GMOs and plant protection products, also for the environment; the guarantees given by the third country that: conditions applied to the establishments from which animals or goods are exported to the Union comply with requirements that are equivalent to those referred to in Article 126(1); a list of the establishments referred to in point (i) is drawn up and kept up to date; the list of establishments referred to in point (i) and updates thereof are communicated to the Commission without delay; the establishments referred to in point (i) are the subject of regular and effective controls by the competent authorities of the third country; the findings of controls performed by the Commission in the third country in accordance with Article 120(1); any other information or data on the capability of the third country to ensure that only animals or goods which provide the same or an equivalent level of protection as that afforded by the relevant requirements referred to in Article 126(1) enter the Union. The Commission shall delete the reference to a third country or a region of a third country from the list referred to in point (a) of Article 126(2) where the conditions for inclusion on the list cease to be met. The procedure referred to in paragraph 2 of this Article shall apply. Where, in cases other than those referred to in Article 53 of Regulation (EC) No 178/2002 and Article 249 of Regulation (EU) 2016/429, there is evidence that the entry into the Union of certain animals or goods originating from a third country, a region thereof or a group of third countries, pose a risk to human, animal or plant health or, as regards GMOs, also to the environment, or where there is evidence that widespread serious non-compliance with the rules referred to in Article 1(2) of this Regulation is taking place, the Commission shall adopt, by means of implementing acts, the measures necessary to contain such risk or put an end to the identified non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2) of this Regulation. The measures referred to in paragraph 1 shall identify animals and goods by referring to their codes from the Combined Nomenclature, and may include: the prohibition of entry into the Union of the animals and goods referred to in paragraph 1 originating in or dispatched from the third countries concerned or regions thereof; the requirement that the animals and goods referred to in paragraph 1 originating in or dispatched from certain third countries or regions thereof be subject, prior to dispatch, to specific treatment or controls; the requirement that the animals and goods referred to in paragraph 1 originating in or dispatched from certain third countries or regions thereof be subject, upon entry into the Union, to specific treatment or controls; the requirement that consignments of the animals and goods referred to in paragraph 1 of this Article originating in or dispatched from certain third countries or regions thereof, be accompanied by an official certificate, an official attestation, or by any other evidence that the consignment complies with requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto; the requirement that the evidence referred to in point (d) be provided in accordance with a specific format; other measures necessary to contain the risk. When adopting the measures referred to in paragraph 2, account shall be taken of: the information collected in accordance with Article 125; any other information that the third countries concerned have provided; and where necessary, the results of Commission controls provided for in Article 120(1). On duly justified imperative grounds of urgency relating to human health and animal health or, as regards GMOs and plant protection products, also to the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3). In the areas governed by the rules referred to in Article 1(2), with the exclusion of points (d), (e), (g), and (h) of Article 1(2), the Commission may, by means of implementing acts, recognise that measures applied in a third country, or regions thereof, are equivalent to the requirements laid down in those rules, on the basis of: a thorough examination of information and data provided by the third country concerned pursuant to Article 125(1); and where appropriate, the satisfactory outcome of a control performed in accordance with Article 120(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). The implementing acts referred to in paragraph 1 shall set out the practical arrangements for the entry of animals and goods into the Union from the third country concerned, or regions thereof, and may include: the nature and content of the official certificates or attestations that have to accompany the animals or goods; specific requirements applicable to the entry into the Union of the animals or goods and the official controls to be performed at entry into the Union; where necessary, procedures for drawing up and amending lists of regions or establishments in the third country concerned from which the entry of animals and goods into the Union is permitted. The Commission shall, by means of implementing acts, repeal without delay the implementing acts provided for in paragraph 1 of this Article where any of the conditions for the recognition of equivalence cease to be fulfilled. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.