Message 001
Communication from the Commission - TRIS/(2025) 2215
Directive (EU) 2015/1535
Notification: 2025/0452/CZ
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20252215.EN
1. MSG 001 IND 2025 0452 CZ EN 19-08-2025 CZ NOTIF
2. Czechia
3A. Úřad pro technickou normalizaci, metrologii a státní zkušebnictví
Biskupský dvůr 1148/5
110 00 Praha 1
tel: +420 221 802 216
e-mail: eu9834@unmz.gov.cz
3B. Sekce ekologického zemědělství, komodit, výzkumu a vzdělávání
Odbor živočišných komodit a ochrany zvířat
Ministerstvo zemědělství
Těšnov 65/17, Praha 1, 117 05
tel: +420 221 812 234
4. 2025/0452/CZ - C90A - Well-being of animals and pets
5. Draft Decree amending Decree No 419/2012 on the protection of experimental animals, as amended
6. protection of animals, experiment, experimental animal, animals used for scientific purposes, administrative procedure, authorisation to breed experimental animals, authorisation to supply experimental animals, authorisation to use experimental animals
7.
8. In order to transpose Commission Delegated Directive (EU) 2024/1262 of 13 March 2024 amending Directive 2010/63/EU of the European Parliament and of the Council as regards the requirements for establishments and for the care and accommodation of animals, and as regards the methods of killing animals, the amendment to the Decree introduces changes concerning the requirements for establishments for the breeding, supply and use of experimental animals, for the care and accommodation of experimental animals, and the methods of killing experimental animals. The new requirements concern the care and accommodation of cephalopods, fish (especially zebrafish (Danio rerio)) and captive-bred songbirds, as well as the killing of cephalopods. Provisions relating to noise and vibration and to emergency plans are being added. For zebrafish, killing by hypothermal shock is now permitted. For rodents, on the other hand, the use of inert gases (argon and nitrogen) for killing them is now prohibited.
The only proposed amendment to the Decree not necessitated by the transposition of the above-mentioned Directive is that applicants for authorisation to breed experimental animals, authorisation to supply experimental animals or authorisation to use experimental animals will be required to submit to assessors, as part of the administrative procedure, a strategy for maintaining the health of experimental animals in accordance with Annex 8(a)(1) to this Decree when submitting their initial application, rather than only when submitting a subsequent application for a further period.
The draft does not contain references to national technical standards, technical documents or company standards, nor to European standards, harmonised standards or international standards containing a national annex, a national note or, where appropriate, a recommendation. The draft contains references to European legislation – Directive 2024/1262/EU and Directive 2010/63/EU.
Keywords:
protection of animals, experiment, experimental animal, animals used for scientific purposes, administrative procedure, authorisation to breed experimental animals, authorisation to supply experimental animals, authorisation to use experimental animals
Most recent notification of the Decree: 2020/0840/CZ, most recent notification of the basic legal text (the Animal Protection Act): 2024/0543/CZ
9. The aim of the submitted draft amendment to the Decree on the protection of experimental animals is to transpose Commission Delegated Directive (EU) 2024/1262 of 13 March 2024 amending Directive 2010/63/EU of the European Parliament and of the Council as regards the requirements for establishments and for the care and accommodation of animals, and as regards the methods of killing animals.
In accordance with the requirements of the Directive, the Decree is proposed to come into effect on 4 December 2026.
A new subparagraph (k) is added to § 3(1) of the Decree, which contains a requirement for applicants to also submit to assessors a strategy for maintaining the health of experimental animals. Applicants are already required under the Decree on the protection of experimental animals to have this strategy drawn up and to submit it to assessors as part of the administrative procedure for granting authorisation to breed, supply or use experimental animals. The only new element is that applicants for authorisation to breed experimental animals, authorisation to supply experimental animals or authorisation to use experimental animals will be required to submit to assessors, as part of the administrative procedure, a strategy for maintaining the health of experimental animals in accordance with Annex 8(a)(1) to this Decree when submitting their initial application, rather than only when submitting a subsequent application for a further period. The change is introduced based on assessors' practical experience with assessing breeding, supplying and user establishments. This new point therefore does not entail any increase in the administrative burden on applicants.
10. Reference(s) to basic text(s): 2020/0840/CZ, 2024/0543/CZ
The basic texts were forwarded with an earlier notification:
2020/0840/CZ
2024/0543/CZ
11. No
12.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
