S.I. No. 226/2026 - European Communities (Food Supplements) (Amendment) Regulations 2026

1. These Regulations may be cited as the European Communities (Food Supplements) (Amendment) Regulations 2026.

2. In these Regulations “Principal Regulations” means European Communities (Food Supplements) Regulations 2007 (S.I. No. 506 of 2007).

3. Regulation 2(1) of the Principal Regulations is amended -

(a) after the definition of “Act of 1998”, by inserting the following

‘“Annex I’ means Annex I to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002

1

, as amended by Commission Regulation (EC) No. 1170/2009 of 30 November 2009

7

and Commission Regulation (EC) 2021/418 of 9 March 2021

8

;

‘Annex II’ means Annex II to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002

1

, as amended by Commission Regulation (EC) No. 1170/2009 of 30 November 2009

7

, Commission Regulation (EC) No. 1161/2011 of 14 November 2011

9

, Commission Regulation (EC) No. 119/2014 of 7 February 2014

10

, Commission Regulation (EC) 2015/414 of 12 March 2015

11

, Commission Regulation (EC) 2017/1203 of 5 July 2017

12

, Commission Regulation (EC) 2021/418 of 9 March 2021

8

, Commission Regulation (EC) 2024/248 of 16 January 2024

2

, Commission Regulation (EU) 2024/1821 of 25 June 2024

3

, Commission Regulation (EU) 2025/352 of 21 February 2025

4

, Commission Regulation (EU) 2025/2224 of 5 November 2025

5

and Commission Regulation (EU) 2025/2225 of 5 November 2025

6

;”,

(b) by substituting for the definition of “Directive” (inserted by Regulation 3 of (S.I. No. 540 of 2021)) the following

“‘Directive’ means Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002

1

, as amended by Commission Directive 2006/37/EC of 30 March 2006

13

, Commission Regulation (EC) No. 1170/2009 of 30 November 2009

7

, Commission Regulation (EU) No. 1161/2011 of 14 November 2011

9

, Commission Regulation (EU) No. 119/2014 of 7 February 2014

10

, Commission Regulation (EU) 2015/414 of 12 March 2015

11

, Commission Regulation (EU) 2017/1203 of 5 July 2017

12

, Commission Regulation (EU) 2021/418 of 9 March 2021

8

, Commission Regulation (EU) 2024/248 of 16 January 2024

2

, Commission Regulation (EU) 2024/1821 of 25 June 2024

3

, Commission Regulation (EU) 2025/352 of 21 February 2025

4

, Commission Regulation (EU) 2025/2224 of 5 November 2025

5

and Commission Regulation (EU) 2025/2225 of 5 November 2025

6

;”,

(c) by substituting for the definition of “the Minister” the following

“‘Minister’ means Minister for Health;”,

(d) by substituting for the definition of “Official Controls Regulation” the following

“‘Official Controls Regulation’ means Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017

14

as amended by Commission Delegated Regulation (EU) 2019/478 of 14 January 2019

15

;”,

and

(e) by inserting after the definition of “official laboratory” the following

“‘relevant thing’ means –

(a) a label, labelling, packaging or container related to food, or

(b) materials used in the presentation or advertising of food or other accompanying material;”.

4. In Regulation 2 of the Principal Regulations, paragraph (3) is deleted.

5. The Principal Regulations are amended—

(a) in paragraphs (1) and (4) of Regulation 4, and in paragraph (6) of Regulation 5, by substituting “Annex I” for “Schedule 1”, and

(b) in paragraphs (1), (2), (3) and (4) of Regulation 4, by substituting “Annex II” for “Schedule 2”.

6. The Principal Regulations are amended by substituting for Regulations 9, 10, 11, and 12 the following

“9. (1) An authorised officer may, for the purposes of these Regulations, purchase or take without payment a sample of food or relevant thing.

(2) An authorised officer may, for the purpose of taking a sample of food open any receptacle.

(3) An authorised officer may, for the purposes of these Regulations, inspect, take or make copies, whether in writing, by photography, electronically or otherwise, of a relevant thing.

(4) Subject to paragraphs (5) and (6), an authorised officer who purchases or takes without payment a sample of food or any relevant thing, with the intention of having it analysed, tested or inspected in the context of official controls, shall, at the time of such purchasing or taking, notify the food business operator or the person in apparent charge or control of the food or relevant thing of his or her intention of having the sample analysed, tested or inspected.

(5) In the case of food or a relevant thing offered for sale by means of distance communication, an authorised officer may order samples without identifying himself or herself.

(6) Where a sample is obtained under paragraph (5), the authorised officer shall take all reasonable steps to ensure that the person from whom the sample is ordered—

(a) is informed that such sample has been taken in the context of an official control and, where appropriate, is analysed, tested or inspected for the purposes of such official control, and

(b) where the sample is analysed or tested, is able to exercise his or her right to a second expert opinion under Article 35(1) of the Official Controls Regulation and Regulation 10.

(7) An authorised officer who suspects that food or a relevant thing fails to comply with these Regulations, and who purchases or takes a sample of that food or relevant thing without payment, with the intention of having it analysed, tested or inspected in the context of official controls, may, by notice in writing to the food business operator, or the person in apparent charge or control of such food or relevant thing, prohibit its removal except to any place which may be specified in the notice, during such period as may be specified in the notice, but not exceeding 15 working days from the date of the taking of the sample.

(8) An authorised officer who serves a notice under paragraph (7) may, by further notice in writing to the recipient of the first notice, extend the period during which the removal of the food or relevant thing is prohibited for a further period specified in the second notice not exceeding 10 working days, provided that such extension is necessary for the purposes of completing analysis, testing or inspection of the food or relevant thing.

7. Regulation 16 of the Principal Regulations is amended by—

(a) substituting for paragraph (1) (inserted by Regulation 6 of

S.I. No. 540 of 2021

) the following

“16 (1) A person who fails to comply with Regulation 4(1), 5 or 6 is guilty of an offence and is liable—

(a) on summary conviction, to a class A fine or to imprisonment for a term not exceeding 6 months, or both, or

(b) on conviction on indictment, to a fine not exceeding €500,000 or to imprisonment for a term not exceeding 2 years, or both.”,

(b) in paragraph (3), by substituting “is guilty of an offence and is liable on summary conviction to a class A fine” for “is guilty of an offence”, and

(c) by inserting after paragraph (3) the following

“(4) Where a person is convicted of an offence under paragraph (1), the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the Authority or the official agency, as the case may be, the costs and expenses, measured by the court, incurred by the Authority or official agency in relation to the investigation, detection and prosecution of the offence, including costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisors engaged by the Authority or official agency.

(5) An order for costs and expenses under paragraph (4) is in addition to, and not instead of, any fine or penalty the court may impose under paragraph (1).”.

8. Regulation 18 of the Principal Regulations is amended by inserting after paragraph (5) the following

“(6) A person who is guilty of an offence under this Regulation is liable—

(a) on summary conviction, to a class A fine or to imprisonment for a term not exceeding 6 months, or both, or

(b) on conviction on indictment, to a fine not exceeding €500,000 or to imprisonment for a term not exceeding 2 years, or both.”.

9. Regulation 19 of the Principal Regulations is deleted.

10. The Principal Regulations are amended by substituting for Regulation 20 the following

“20. An offence under these Regulations may be brought and prosecuted summarily by the Authority or an official agency.”.

11. Schedules 1 and 2 to the Principal Regulations are deleted.

12. The following are revoked

(a) the European Communities (Food Supplements) (Amendment) Regulations 2021 (

S.I. No. 540 of 2021

);

(b) the European Communities (Food Supplements) (Amendment) Regulations 2018 (

S.I. No. 225 of 2018

);

(c) the European Communities (Food Supplements) (Amendment) Regulations 2015 (

S.I. No. 282 of 2015

);

(d) the European Communities (Food Supplements) (Amendment) Regulations 2010 (

S.I. No. 355 of 2010

).

GIVEN under my Official Seal,

27 May, 2026.

JENNIFER CARROLL MACNEILL,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations which relate to food supplements —

• give further effect to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 and full effect to to the Commission Regulations that amend an Annex to that Directive; and

• amend the European Communities (Food Supplements) Regulations 2007 (

S.I. No. 506 of 2007

).

1 OJ No. L 183 12.7.2002, p. 51.

2 OJ L, 2024/248, 17.1.2024.

3 OJ L, 2024/1821, 27.6.2024.

4 OJ L, 2025/352, 24.2.2025.

5 OJ L, 2025/2224, 6.11.2025.

6 OJ L, 2025/2225, 6.11.2025.

1 OJ No. L 183 12.7.2002, p. 51.

7 OJ No. L 314, 1.12.2009, p. 36.

8 OJ No. L 83, 10.3.2021, p. 1.

1 OJ No. L 183 12.7.2002, p. 51.

7 OJ No. L 314, 1.12.2009, p. 36.

9 OJ No. L 296, 15.11.2011, p. 29.

10 OJ No. L 39, 8.2.2014, p. 44.

11 OJ No. L 68, 13.3.2015, p. 26.

12 OJ No. L 173, 6.7.2017, p. 9.

8 OJ No. L 83, 10.3.2021, p. 1.

2 OJ L, 2024/248, 17.1.2024.

3 OJ L, 2024/1821, 27.6.2024.

4 OJ L, 2025/352, 24.2.2025.

5 OJ L, 2025/2224, 6.11.2025.

6 OJ L, 2025/2225, 6.11.2025.

1 OJ No. L 183 12.7.2002, p. 51.

13 OJ No. L 94, 1.4.2006, p. 32.

7 OJ No. L 314, 1.12.2009, p. 36.

9 OJ No. L 296, 15.11.2011, p. 29.

10 OJ No. L 39, 8.2.2014, p. 44.

11 OJ No. L 68, 13.3.2015, p. 26.

12 OJ No. L 173, 6.7.2017, p. 9.

8 OJ No. L 83, 10.3.2021, p. 1.

2 OJ L, 2024/248, 17.1.2024.

3 OJ L, 2024/1821, 27.6.2024.

4 OJ L, 2025/352, 24.2.2025.

5 OJ L, 2025/2224, 6.11.2025.

6 OJ L, 2025/2225, 6.11.2025.

14 OJ No. L 95, 7.4.2017, p. 1.

15 OJ No. L 82, 25.3.2019, p. 4.

12A. Where the results of an analysis, test or inspection carried out on a sample of food or a relevant thing during official controls or other official activities indicate a risk to human health or point to the likelihood of non-compliance with these Regulations, the official laboratory concerned shall immediately inform the Authority and the official agency.

12B. (1) The approved examiner or a person under his or her direction shall analyse as soon as possible any sample of food or any relevant thing, or a copy or photograph thereof, submitted to him or her in pursuance of these Regulations and, in accordance with the criteria set out in Annex III to the Official Controls Regulation, the approved examiner shall certify to the person who submitted the sample to him or her the result of such analysis.

(2) For the purposes of paragraph (1), the form of certificate set out in Schedule 3, or a certificate in like form, shall be used.

(3) An official certificate given in accordance with paragraph (1) shall be evidence of the matters contained therein until the contrary is shown.”.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

29

th May,

2026.

I, JENNIFER CARROLL MACNEILL, Minister for Health, 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 further effect to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002

1

, and full effect to Commission Regulation (EU) 2024/248 of 16 January 2024

2

, Commission Regulation (EU) 2024/1821 of 25 June 2024

3

, Commission Regulation (EU) 2025/352 of 21 February 2025

4

, Commission Regulation (EU) 2025/2224 of 5 November 2025

5

, and Commission Regulation (EU) 2025/2225 of 5 November 2025

6

, hereby make the following regulations