S.I. No. 561/2025 - European Union (Simple Pressure Vessels) (Amendment) Regulations 2025
Notice of the making of this Statutory Instrument was published in | ||
“Iris Oifigiúil” of 27th November, 2025. | ||
I, PETER BURKE, Minister for Enterprise, Tourism and Employment, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving full effect to Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 20191 hereby make the following regulations: | ||
Citation | ||
1. These Regulations may be cited as the European Union (Simple Pressure Vessels) (Amendment) Regulations 2025. | ||
Definition | ||
2. In these Regulations, “Principal Regulations” means the European Union (Simple Pressure Vessels) Regulations 2016 (S. I. No. 227 of 2016). | ||
Amendment of Regulation 2 of Principal Regulations | ||
3. Regulation 2 of the Principal Regulations is amended – | ||
(a) in paragraph (1) – | ||
(i) by the insertion of the following definition: | ||
“ ‘Regulation (EU) 2019/1020’ means Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No. 765/2008 and (EU) No. 305/2011;”, and | ||
(ii) by the substitution of the following definitions for the definitions of “authorised representative” and “economic operator”: | ||
“ ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer’s obligations under the relevant Union harmonisation legislation or under the requirement of these Regulations or Regulation (EU) 2019/1020; | ||
‘economic operator’ means – | ||
(a) a manufacturer, | ||
(b) an authorised representative, | ||
(c) an importer, | ||
(d) a distributor, | ||
(e) a fulfilment service provider, or | ||
(f) or any other natural or legal person who is subject to obligations in relation to the manufacture of vessels, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation;”, and | ||
(b) by the insertion of the following paragraph after paragraph (2): | ||
“(3) A word or expression which is used in these Regulations and which is also used in Regulation (EU) 2019/1020 has, unless the context otherwise requires, the same meaning in these Regulations as it has in Regulation (EU) 2019/1020.”. | ||
Amendment of Regulation 5 of Principal Regulations | ||
4. The Principal Regulations are amended by the substitution of the following Regulation for Regulation 5: | ||
“Making available on the market and putting into service | ||
5. (1) An economic operator shall not make available on the market or put into service a vessel unless it satisfies the requirements of these Regulations when properly installed and maintained and used for the purposes for which it is intended. | ||
(2) A vessel may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in article 4(3) of Regulation 2019/1020 in respect of that vessel.”. | ||
Amendment of Regulation 7 of Principal Regulations | ||
5. Regulation 7 of the Principal Regulations is amended – | ||
(a) in paragraph (i), in subparagraph (ii), by the substitution of “taken” for “taken, and”, | ||
(b) in paragraph (j), in subparagraph (ii), by the substitution of “the manufacturer,” for “the manufacturer”, and | ||
(c) by the insertion of the following subparagraphs after subparagraph (j): | ||
“(k) further to a reasoned request from a market surveillance authority provide the market surveillance authority with all information and documentation (in English or in a language that can be easily understood by that authority) necessary to demonstrate the conformity of a vessel, | ||
(l) inform the market surveillance authority when the manufacturer has reason to believe that the vessel concerned presents a risk, | ||
(m) cooperate with the market surveillance authority, including following a reasoned request, to ensure that the immediate, necessary and corrective action is taken to remedy any non-compliance with the requirements set out in Union harmonisation legislation applicable to the vessel, or if that is not possible, to mitigate the risks presented by the vessel at the request of the market surveillance authority or on its own initiative where the manufacturer has reason to believe that the product in question presents a risk.”, | ||
Amendment of Regulation 8 of Principal Regulations | ||
6. Regulation 8 of the Principal Regulations is amended – | ||
(a) in paragraph (3) – | ||
(i) in subparagraph (b), by the substitution of “a vessel,” for “a vessel, and”, | ||
(ii) in subparagraph (c), by the substitution of “the authorised representative’s mandate,” for “the authorised representative’s mandate.”, and | ||
(iii) by the insertion of the following subparagraphs after subparagraph (c): | ||
“(d) provide the market surveillance authority, further to a reasoned request from that authority, with all information and documentation (in English or in a language that can be easily understood by that authority) necessary to demonstrate the conformity of a vessel, and | ||
(e) inform the market surveillance authority when the manufacturer has reason to believe that the vessel concerned presents a risk.”, and | ||
(b) by the insertion of the following paragraphs after paragraph (3): | ||
“(4) For the purposes of point (c) of Article 4(2) of Regulation (EU) 2019/1020, the manufacturer shall mandate the authorised representative to perform the tasks mentioned in Article 4(3) of the Regulation, notwithstanding any other tasks mandated under the relevant Union harmonisation legislation. | ||
(5) The authorised representative shall – | ||
(a) perform the tasks specified in the mandate referred to in paragraph (4), and | ||
(b) provide a copy of that mandate to the market surveillance authorities upon request, in a Union language determined by the market surveillance authority. | ||
(6) Authorised representatives shall have the appropriate means to be able to fulfil their tasks.”. | ||
Amendment of Regulation 9 of Principal Regulations | ||
7. Regulation 9 of the Principal Regulations is amended, in paragraph (2), | ||
(a) in subparagraph (i)(ii) by the substitution of “placed on the market,” for “placed on the market, and”, | ||
(b) in subparagraph (j)(ii) by the substitution of “placed on the market,” for “placed on the market.”, and | ||
(c) by the insertion of the following subparagraph after subparagraph (j): | ||
“(k) cooperate with the market surveillance authority, including following a reasoned request, to ensure that the immediate, necessary and corrective action is taken to remedy any non-compliance with the requirements set out in Union harmonisation legislation applicable to the vessel concerned, or if that is not possible, to mitigate the risks presented by the vessel at the request of the market surveillance authority or on its own initiative where the manufacturer has reason to believe that the product in question presents a risk.”. | ||
Amendment of Regulation 10 of Principal Regulations | ||
8. Regulation 10 of the Principal Regulations is amended – | ||
(a) in paragraph (f)(ii), by the substitution of “any corrective measures taken,” for “any corrective measures taken, and”, | ||
(b) in paragraph (g)(ii), by the substitution of “placed on the market,” for “placed on the market.”, and | ||
(c) by the insertion of the following paragraphs after paragraph (g): | ||
“(h) further to a reasoned request from a market surveillance authority provide the market surveillance authority with all information and documentation (in English or in a language that can be easily understood by that authority) necessary to demonstrate the conformity of a vessel, | ||
(i) inform the market surveillance authority where the vessel presents a risk, and | ||
(j) cooperate with the market surveillance authority at its request on any action to remedy any non-compliance with the requirements of the Regulations or if that is not possible, to mitigate the risks posed by the vessel at the request of the market surveillance authority or on its own initiative where the manufacturer has reason to believe that the product in question presents a risk.”. | ||
Amendment of Regulation 25 of Principal Regulations | ||
9. Regulation 25 of the Principal Regulations is amended in paragraph (1) by the substitution of “Regulation (EU) 2019/1020” for “Articles 16 to 29 of Regulation (EC) No. 765 of 2008”. | ||
Amendment of Regulation 26 of Principal Regulations | ||
10. Regulation 26 of the Principal Regulations is amended – | ||
(a) in paragraph (3) – | ||
(i) by the substitution of the following subparagraph for subparagraph (a): | ||
“(a) without delay require the relevant economic operator to – | ||
(i) take all appropriate measures to ensure that the vessel concerned, when placed on the market, no longer presents that risk, to withdraw the vessel from the market, | ||
(ii) recall the vessel within a reasonable period, | ||
(iii) destroy the vessel concerned or | ||
(iv) otherwise render it inoperable, | ||
commensurate with the nature of the risk, as it may require,”, and | ||
(ii) by the substitution of the following subparagraph for subparagraph (c): | ||
“(c) apply the provisions of Article 18 of Regulation (EU) 2019/1020 to the measures referred to in subparagraph (a).”, and | ||
(b) by the insertion of the following paragraphs after paragraph (10): | ||
“(11) The information to the European Commission and the other Member States pursuant to paragraph (7) shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 which communication shall be deemed to fulfil notification requirements of the safeguard procedures of the Directive. | ||
(12) The market surveillance authority shall provide the customs authority with information on categories of vessels or the identity of economic operators where a higher risk of non-compliance has been identified. | ||
(13) Where the market surveillance authority has reasonable grounds to believe that a vessel does not comply with the Directive or presents a serious risk, it shall request the customs authority to suspend the process for its release for free circulation. | ||
(14) Where the release of a vessel for free circulation has been suspended in accordance with paragraph (13), that vessel shall be released for free circulation where all the other requirements and formalities relating to such a release have been fulfilled and where either of the following conditions is satisfied – | ||
(a) within four working days of the suspension, the customs authority has not been requested by the market surveillance authority to maintain the suspension, or | ||
(b) the customs authority has been informed by the market surveillance authority of its approval for release for free circulation. | ||
(15) The release of a vessel for free circulation in accordance with paragraph (14) shall not be deemed to be proof of conformity with the Directive. | ||
(16) Where the market surveillance authority concludes that a vessel presents a serious risk, it shall – | ||
(a) take measures to prohibit the placing of the product on the market, | ||
(b) require the customs authority not to release the vessel for free circulation, and | ||
(c) require the customs authority to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the vessel and on any other relevant accompanying document: | ||
‘Dangerous product – release for free circulation not authorised – Regulation (EU) 2019/1020’. | ||
(17) Where the market surveillance authority concludes that a vessel may not be placed on the market since it does not comply with the Directive, it shall – | ||
(a) take measures to prohibit the placing of the vessel on the market, | ||
(b) require the customs authority not to release the vessel for free circulation, and | ||
(c) require those authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the vessel and on any other relevant accompanying document: | ||
‘Product not in conformity – release for free circulation not authorised – Regulation (EU) 2019/1020’. | ||
(18) The market surveillance authority shall immediately enter the information referred to in paragraph (17) in the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. | ||
(19) The market surveillance authority shall enter into the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 in relation to vessels made available on the market for which an in-depth check of compliance has been carried out, without prejudice to Article 12 of Directive 2001/95/EC and Article 20 of Regulation (EU) 2019/1020, and where applicable, in relation to vessels entering the Union market for which the process for the release for free circulation has been suspended in accordance with Regulation 9 (3) of these Regulations, the following information concerning: | ||
(a) measures according to Regulation 26 (3); | ||
(b) reports of testing carried out by the market surveillance authority; | ||
(c) corrective action taken by economic operators concerned; | ||
(d) readily available reports on injuries caused by the product in question; | ||
(e) any objection raised by a Member State in accordance with the applicable safeguard procedure in the Council Directive and any subsequent follow-up; | ||
(f) where available, failures by manufacturers to comply with Regulation 8 (4); | ||
(g) where available, failures by authorised representatives to comply with Regulation 8 (5).”. | ||
Amendment of Regulation 28 of Principal Regulations | ||
11. Regulation 28 of the Principal Regulations is amended – | ||
(a) in paragraph (1) by the substitution of the following subparagraph for subparagraph (a): | ||
“(a) without delay require the relevant economic operator to – | ||
(i) take all appropriate measures to ensure that the vessel concerned, when placed on the market, no longer presents that risk, | ||
(ii) withdraw the vessel from the market, | ||
(iii) recall it within a reasonable period, or | ||
(iv) destroy the vessel concerned or otherwise render it inoperable, | ||
commensurate with the nature of the risk, as it may require,”, and | ||
(b) by the insertion of the following paragraphs after paragraph (2): | ||
“(3) Where the relevant economic operator fails to comply with paragraph (1) or where the non-compliance or the risk referred to in that paragraph persists, the market surveillance authority shall ensure that the vessel is withdrawn or recalled, or that its being made available on the market is prohibited or restricted, and that the public, the Commission and the other Members States are informed accordingly. | ||
(4) The information to the European Commission and the other Member States referred to in paragraph (3) shall be communicated through the information and communication system referred to in article 34 of Regulation (EU) 2019/1020 which shall be deemed to fulfil notification requirements of the safeguard procedures of the Directive.”. | ||
Amendment of Regulation 30 of Principal Regulations | ||
12. The Principal Regulations are amended by the insertion of the following Regulation after Regulation 30: | ||
“30A. (1) An authorised officer shall, for the purpose of enforcement of the Market Surveillance Regulation and these Regulations, have the power to do one or more of the following – | ||
(a) require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including access to embedded software in so far as such access is necessary for the purpose of assessing the product’s compliance with applicable Union harmonisation legislation, in any form or format and irrespective of the medium of storage or the place where such documents, technical specifications, data or information are stored, and to take or obtain copies thereof, | ||
(b) require economic operators to provide relevant information on the supply chain, on the details of the distribution network, on quantities of products on the market and on other product models that have the same technical characteristics as the product in question, where relevant for compliance with the applicable requirements under Union harmonisation legislation, | ||
(c) require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites, where the information in question is related to the subject matter of the investigation, | ||
(d) carry out unannounced on-site inspections and physical checks of products, | ||
(e) enter any premises, land or means of transport that the economic operator in question uses for purposes related to the economic operator’s trade, business, craft or profession, in order to identify non-compliance and to obtain evidence, | ||
(f) start investigations on his or her own initiative in order to identify non-compliances and bring them to an end, | ||
(g) require economic operators to take appropriate action to bring an instance of non-compliance to an end or to eliminate the risk, | ||
(h) take appropriate measures where an economic operator fails to take appropriate corrective action or where the non-compliance or the risk persists, including the power to prohibit or restrict the making available of a product on the market or to order that the product is withdrawn or recalled, | ||
(i) acquire product samples, including under a cover identity, to inspect those samples and to reverse-engineer them in order to identify non-compliance and to obtain evidence, | ||
(j) where no other effective means are available to eliminate a serious risk – | ||
(i) to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface, or | ||
(ii) where a request according to subparagraph (i) has not been complied with, to require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures, | ||
(k) cause any simple pressure vessel or any article or substance used in the manufacture of a simple pressure vessel found at or in any premises which appears to the authorised officer to present a serious risk to be destroyed or otherwise rendered inoperable where deemed necessary by the officer, or subjected to any process or test and where an authorised officer proposes to exercise this power in the case of a simple pressure vessel or an article or substance used in the manufacture of a simple pressure vessel found at or in any premises, the authorised officer shall, if so requested by a person who at the time is present at or in and has responsibilities in relation to that premises, and if it is practicable and safe to do so, cause anything which is to be done by virtue of that power to be done in the presence of that person, and | ||
(l) take possession, in relation to any simple pressure vessel or any article or substance used in the manufacture of a simple pressure vessel found at a premises in accordance with subparagraph (k), and detain it for so long as is necessary for all or any of the following purposes: | ||
(i) to examine or arrange for the examination of it and do to it anything which he or she has power to do under subparagraph (k); | ||
(ii) to ensure that it is not tampered with before the examination of it is completed; | ||
(iii) to ensure that it is available for use as evidence in any proceedings. | ||
(2) An authorised officer may use any information, document, finding, statement, or any intelligence as evidence for the purpose of his or her investigations, irrespective of the format in which and medium on which they are stored. | ||
(3) Before exercising the power conferred by paragraph (1)(l), in the case of any simple pressure vessel, an authorised officer shall, in so far as it is reasonably practicable to do so, consult such persons as appear to him or her to be appropriate for the purpose of ascertaining what dangers, if any, there may be in doing anything which he or she proposes to do under that power. | ||
(4) Where, under the power conferred by paragraph (1)(l), an authorised officer takes possession of any simple pressure vessel, article or substance found at or in any premises, the officer shall, if it is practicable for him or her to do so, take a sample thereof and give to a responsible person at the premises a portion of the sample marked in a manner sufficient to identify it. | ||
(5) An authorised officer shall not, other than with the consent of the occupier, enter a private dwelling unless he or she has obtained a warrant from the District Court under paragraph (8) authorising such entry. | ||
(6) Where an authorised officer, in the exercise of the officer’s powers under these Regulations, is prevented from entering any premises, an application may be made to the District Court under paragraph (8) for a warrant authorising such entry. | ||
(7) An authorised officer, where he or she considers it necessary, may be accompanied by a member of An Garda Síochána when performing any powers conferred on an authorised officer under these Regulations. | ||
(8) If a judge of the District Court is satisfied on the sworn information of an authorised officer that there are reasonable grounds for suspecting that there is information required by an authorised officer under these Regulations held on any premises or any part of any premises or there is a simple pressure vessel which an authorised officer requires to inspect for the purposes of these Regulations or the Market Surveillance Regulation or that such inspection is likely to disclose evidence of a contravention of these Regulations or the Market Surveillance Regulation, the judge may issue a warrant authorising an authorised officer, whether alone or accompanied by other authorised officers or members of An Garda Síochána, at any time or times within one month from the date of issue of the warrant, on production if so requested of the warrant, to enter, if need be by reasonable force, the premises and exercise all or any of the powers conferred on an authorised officer under these Regulations. | ||
(9) An application under paragraph (8) shall be made to the judge of the District Court in whose District Court district the premises is situated. | ||
(10) A person shall not – | ||
(a) obstruct or interfere with an authorised officer in the exercise of the officer’s powers under this Regulation, | ||
(b) without reasonable excuse fail to comply with a request from an authorised officer under this Regulation, or | ||
(c) make a statement to such officer which the person knows is false or misleading.”. | ||
13. Regulation 33 of the Principal Regulations is amended – | ||
(a) in paragraph (1) – | ||
(i) in subparagraph (a)(iii) by the substitution of “of the vessel,” for “of the vessel, and”, | ||
(ii) in subparagraph (b) by the substitution of “these Regulations, and” for “these Regulations.”, and | ||
(iii) by the insertion of the following subparagraph after subparagraph (b): | ||
“(c) shall, in accordance with Article 20 of Regulation (EU) 2019/1020, immediately notify the European Commission of a measure taken under subparagraphs (a) and (b).”, and | ||
(b) by the insertion of the following paragraph after paragraph (1): | ||
“(1A) (i) An ascertainment under paragraph (1) as to whether or not a vessel presents a serious risk shall be based on an appropriate risk assessment that takes account of – | ||
(I) the nature of the hazard, and | ||
(II) the likelihood of its occurrence. | ||
(ii) Without prejudice to subparagraph (i), the following shall not constitute grounds of ascertaining that a vessel presents a serious risk – | ||
(I) the feasibility of obtaining higher levels of safety, and | ||
(II) the availability of other vessels presenting a lesser degree of risk.”. | ||
| ||
GIVEN under my Official Seal, | ||
27 November, 2025. | ||
PETER BURKE, | ||
Minister for Enterprise, Tourism and Employment. | ||
EXPLANATORY NOTE | ||
(This note is not part of the Instrument and does not purport to be a legal interpretation.) | ||
These Regulations amend the European Union (Simple Pressure Vessels) Regulations 2016 ( S.I. No. 227 of 2016 ) and give effect to Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products. | ||
The Regulations update and strengthen the existing framework governing the safety and compliance of simple pressure vessels placed or made available on the EU market. | ||
The Regulations enhance market surveillance and enforcement mechanisms by granting additional powers to authorised officers, establishing procedures for cooperation with customs authorities, and setting out requirements for risk assessment, corrective actions, and communication through the EU’s information and communication system. | ||
The Regulations aim to ensure that only compliant and safe simple pressure vessels are made available on the EU market and that appropriate corrective measures are taken where risks or non-compliance are identified. | ||