Access to European Union law
<a href="https://eur-lex.europa.eu/content/help/eurlex-content/experimental-features.html" target="_blank">More about the experimental features corner</a>
Choose the experimental features you want to try
EUR-Lex
Access to European Union law

This document is an excerpt from the EUR-Lex website

You are here
Use quotation marks to search for an "exact phrase". Append an asterisk (*) to a search term to find variations of it (transp*, 32019R*). Use a question mark (?) instead of a single character in your search term to find variations of it (ca?e finds case, cane, care).
Search tips
Need more search options? Use the Advanced search

Document 32016R1444

    Commission Implementing Regulation (EU) 2016/1444 of 31 August 2016 amending Regulation (EU) No 37/2010 as regards the substance hydrocortisone aceponate (Text with EEA relevance)

    C/2016/5499

    IO L 235, 1.9.2016, p. 8–10 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/reg_impl/2016/1444/oj

    1.9.2016   

    EN

    Official Journal of the European Union

    L 235/8

    COMMISSION IMPLEMENTING REGULATION (EU) 2016/1444

    of 31 August 2016

    amending Regulation (EU) No 37/2010 as regards the substance hydrocortisone aceponate

    (Text with EEA relevance)

    THE EUROPEAN COMMISSION,

    Having regard to the Treaty on the Functioning of the European Union,

    Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,

    Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,

    Whereas:

    (1)

    Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (MRL) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation.

    (2)

    Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.

    (3)

    Hydrocortisone aceponate is not yet included in that table.

    (4)

    An application for the establishment of MRLs for hydrocortisone aceponate in bovine species has been submitted to the European Medicines Agency (EMA).

    (5)

    The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for hydrocortisone aceponate in bovine tissues and milk and restricted its use to intramammary use only.

    (6)

    According to Article 5 of Regulation (EC) No 470/2009, the EMA is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.

    (7)

    The EMA has considered that the extrapolation of the MRL for hydrocortisone aceponate from bovine milk to the milk of all ruminants and Equidae is appropriate, while the establishment of an MRL for hydrocortisone aceponate in all other tissues of all ruminants and Equidae is not necessary for the protection of human health.

    (8)

    Regulation (EU) No 37/2010 should therefore be amended accordingly.

    (9)

    It is appropriate to grant the stakeholders concerned a reasonable period of time to take measures that may be required to comply with the new MRL.

    (10)

    The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

    HAS ADOPTED THIS REGULATION:

    Article 1

    The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.

    Article 2

    This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

    It shall apply from 31 October 2016.

    This Regulation shall be binding in its entirety and directly applicable in all Member States.

    Done at Brussels, 31 August 2016.

    For the Commission

    The President

    Jean-Claude JUNCKER

    (1)   OJ L 152, 16.6.2009, p. 11.

    (2)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

    ANNEX

    In Table 1 of the Annex to Regulation (EU) No 37/2010, an entry for the following substance is inserted in alphabetical order:

    Pharmacologically active Substance

    Marker residue

    Animal Species

    MRL

    Target Tissues

    Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)

    Therapeutic Classification

    ‘Hydrocortisone aceponate

    Sum of hydrocortisone and its esters after alkaline hydrolysis expressed as hydrocortisone

    All ruminants, Equidae

    10 μg/kg

    Milk

    For intramammary use only

    Corticosteroids’

    NOT APPLICABLE

    All ruminants, Equidae

    No MRL required for all tissues except milk

    NOT APPLICABLE
    Top