Section 35 of the Act (punishment of offences) applies as...
Unlimited fine- Fail to comply with infant formula regulations Any Person
Welsh Statutory Instrument
2020
Wales
The Infant Formula and Follow-on Formula (Wales) Regulations 2020
At a glance
Enforced by
What's here
18 compliance obligations
Penalty landscape
3 of 18 obligations carry an unlimited fine. 15 have no criminal penalty — flagged in the list below.
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Any Person 12
- Manufacturer 5
- Operator 1
Other Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Any Person also bound by 2338 other Acts (top 5 shown)
- Human Medicines Regulations 2012 2012 169 duties
- Merchant Shipping Act 1995 1995 144 duties
- Insolvency (England and Wales) Rules 2016 2016 101 duties
- Road Traffic Act 1988 1988 95 duties
- Air Navigation Order 2016 2016 95 duties
Manufacturers also bound by 472 other Acts (top 5 shown)
- Pressure Equipment (Safety) Regulations 2016 2016 91 duties
- Lifts Regulations 2016 2016 70 duties
- The Ecodesign for Energy-Related Products and Energy Information Regulations 2021 2021 70 duties
- Non-Automatic Weighing Instruments Regulations 2016 2016 67 duties
- Pyrotechnic Articles (Safety) Regulations 2015 2015 64 duties
Operators also bound by 730 other Acts (top 5 shown)
- Regulation (EU) No 965/2012 (Air Operations) 2012 138 duties
- Commission Implementing Regulation (EU) 2018/2066 of 19 December 2018 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council and amending Commission Regulation (EU) No 601/2012 (Text with EEA relevance) 2018 121 duties
- Commission Regulation (EU) No 601/2012 of 21 June 2012 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council (Text with EEA relevance) (repealed) 2012 112 duties
- Space Industry Regulations 2021 2021 75 duties
- Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (Text with EEA relevance) 2016 66 duties
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Schedules
Section 20 of the Act (offences due to fault of...
Unlimited fine- Cause another business to breach infant formula regulations Any Person
Listed substances and their purity criteria (infant formula and follow-on formula)
- Use only listed substances meeting purity criteria in infant formula manufacturing Any Person
Notification of infant formula
- Notify Welsh Ministers before placing new infant formula in Wales Operator
Pesticide residues (infant formula and follow-on formula)
- Ensure pesticide residues in infant formula and follow-on formula do not exceed specified limits Any Person
Naming of infant formula
- Only sell infant formula under the name 'infant formula' Any Person
Naming of follow-on formula
- Sell follow-on formula only under the name 'follow-on formula' Any Person
Labelling of infant formula
- Label infant formula with mandatory information and restrictions Any Person
Labelling of follow-on formula
- Label follow-on formula with required statements and nutritional information Any Person
Presentation (infant formula and follow-on formula)
- Ensure presentation of infant formula and follow-on formula complies with specified rules Any Person
Restrictions on advertising infant formula
- Do not advertise infant formula except in limited circumstances Any Person
Provision of informational and educational material dealing with the feeding of infants
- Ensure infant feeding informational materials meet content and donation rules Manufacturer
Offences and enforcement
Unlimited fine- Fail to comply with infant formula regulations Any Person
Substances in such quantity as to endanger the health of infants and young children
- Ensure formula does not contain harmful levels of substances Any Person
Protein hydrolysates and other food ingredients suitable for infants from birth (infant formula)
- Demonstrate suitability of protein hydrolysates and novel ingredients in infant formula Manufacturer
Protein hydrolysates and other food ingredients suitable for infants aged over 6 months (follow-on formula)
- Manufacture follow-on formula only from permitted ingredients Manufacturer
Compositional criteria for infant formula
- Ensure infant formula meets compositional criteria and additional evidence for protein hydrolysates Manufacturer
Compositional criteria for follow-on formula
- Ensure follow-on formula meets compositional criteria and conduct studies for certain hydrolysate formulas Manufacturer
Browse 25 other Schedules — structural / supplementary
Section 10 of the Act (improvement notices) applies as if,...
Section 29 of the Act (procurement of samples) applies as...
Section 30 of the Act (analysis etc. of samples) applies...
Section 33 of the Act (obstruction etc. of officers) applies...
Section 36 of the Act (offences by bodies corporate) applies...
Section 36A of the Act (offences by Scottish partnerships) applies...
Section 44 of the Act (protection of officers acting in...
Section 53 (general interpretation) applies as if—
Section 32 of the Act (powers of entry) applies as...
Section 37 of the Act (appeals to magistrates' court or...
Section 39 of the Act (appeals against improvement notices) applies...
Section 3 of the 1990 Act (presumptions that food intended...
Section 21 of the Act (defence of due diligence) applies...
Section 22 of the Act (defence of publication in the...
Interpretation
Prohibitions and limitations on the use of food ingredients (infant formula and follow-on formula)
Avoidance of the risk of confusion between infant formula and follow-on formula
Prohibition on the marketing of infant formula or follow-on formula unless certain conditions are met
Restrictions on advertising follow-on formula
Restrictions on promotion of infant formula
Free or reduced rate infant formula
Application of the improvement notice provisions of the Act
Application of various sections of the Act
Prohibition on the marketing of products other than infant formula for normal healthy infants
Addition of water (infant formula and follow-on formula)
Browse 5 other sections — procedural / definitional / commencement
Title, commencement and application
Interpretation
Enforcement
Application of provisions of the Act
Revocations, savings and transitional provisions
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
Food Standards Agency
Food safety and hygiene regulation across England, Wales, and Northern Ireland. Enforces food law, provides guidance to food businesses, investigates incidents. Approves …
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Browse legislation
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Regulators
Learn more about the bodies that enforce this legislation.