- Enforced by
- FSA
- Status
- In Force
- Penalty ceiling
- Prosecution 3 of 22 obligations carry an unlimited fine. 19 have no criminal penalty — flagged in the list below.
Does it bind you?
Business-side roles with duties under this instrument.
Any Person15
Manufacturer6
Operator1
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Any Person — also bound by 2340 other Acts
Human Medicines Regulations 2012
184 duties
Merchant Shipping Act 1995
144 duties
Insolvency (England and Wales) Rules 2016
104 duties
Communications Act 2003
92 duties
Road Traffic Act 1988
92 duties
Manufacturer — also bound by 502 other Acts
Measuring Instruments Regulations 2016
85 duties
Human Medicines Regulations 2012
75 duties
Operator — also bound by 746 other Acts
Regulation (EU) No 965/2012 (Air Operations)
203 duties
Space Industry Regulations 2021
76 duties
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
5 other provisions — procedural and definitional
s.001
Title, commencement and application
s.002
Interpretation
s.003
Enforcement
s.004
Application of provisions of the Act
s.005
Revocations, savings and transitional provisions
Schedules
Schedules
22 of 43 shown
s.sch002
Section 35 of the Act (punishment of offences) applies as...
Prosecution
- Fail to comply with infant formula regulationsAny Person
Unlimited fine
s.sch002
Section 20 of the Act (offences due to fault of...
Prosecution
- Cause another business to breach infant formula regulationsAny Person
Unlimited fine
s.sch004
Prohibitions and limitations on the use of food ingredients (infant formula and follow-on formula)
Regulated
- Comply with ingredient restrictions in infant formula and follow-on formulaManufacturer
s.sch004
Listed substances and their purity criteria (infant formula and follow-on formula)
Regulated
- Use only listed substances meeting purity criteria in infant formula manufacturingAny Person
s.sch004
Notification of infant formula
Regulated
- Notify Welsh Ministers before placing new infant formula in WalesOperator
s.sch004
Pesticide residues (infant formula and follow-on formula)
Regulated
- Ensure pesticide residues in infant formula and follow-on formula do not exceed specified limitsAny Person
s.sch004
Naming of infant formula
Regulated
- Only sell infant formula under the name 'infant formula'Any Person
s.sch004
Naming of follow-on formula
Regulated
- Sell follow-on formula only under the name 'follow-on formula'Any Person
s.sch004
Labelling of infant formula
Regulated
- Label infant formula with mandatory information and restrictionsAny Person
s.sch004
Labelling of follow-on formula
Regulated
- Label follow-on formula with required statements and nutritional informationAny Person
s.sch004
Avoidance of the risk of confusion between infant formula and follow-on formula
Regulated
- Label infant formula and follow-on formula distinctlyAny Person
s.sch004
Presentation (infant formula and follow-on formula)
Regulated
- Ensure presentation of infant formula and follow-on formula complies with specified rulesAny Person
s.sch004
Restrictions on advertising infant formula
Regulated
- Do not advertise infant formula except in limited circumstancesAny Person
s.sch004
Restrictions on advertising follow-on formula
Regulated
- Do not advertise follow-on formula in breach of advertising rulesAny Person
s.sch004
Provision of informational and educational material dealing with the feeding of infants
Regulated
- Ensure infant feeding informational materials meet content and donation rulesManufacturer
s.sch004
Free or reduced rate infant formula
Regulated
- Use or distribute free/reduced infant formula only for infants who need itAny Person
s.sch004
Offences and enforcement
Prosecution
- Fail to comply with infant formula regulationsAny Person
Unlimited fine
s.sch004
Substances in such quantity as to endanger the health of infants and young children
Regulated
- Ensure formula does not contain harmful levels of substancesAny Person
s.sch004
Protein hydrolysates and other food ingredients suitable for infants from birth (infant formula)
Regulated
- Demonstrate suitability of protein hydrolysates and novel ingredients in infant formulaManufacturer
s.sch004
Protein hydrolysates and other food ingredients suitable for infants aged over 6 months (follow-on formula)
Regulated
- Manufacture follow-on formula only from permitted ingredientsManufacturer
s.sch004
Compositional criteria for infant formula
Regulated
- Ensure infant formula meets compositional criteria and additional evidence for protein hydrolysatesManufacturer
s.sch004
Compositional criteria for follow-on formula
Regulated
- Ensure follow-on formula meets compositional criteria and conduct studies for certain hydrolysate formulasManufacturer
21 other schedules
s.sch002
Section 10 of the Act (improvement notices) applies as if,...
s.sch002
Section 29 of the Act (procurement of samples) applies as...
s.sch002
Section 30 of the Act (analysis etc. of samples) applies...
s.sch002
Section 33 of the Act (obstruction etc. of officers) applies...
s.sch002
Section 36 of the Act (offences by bodies corporate) applies...
s.sch002
Section 36A of the Act (offences by Scottish partnerships) applies...
s.sch002
Section 44 of the Act (protection of officers acting in...
s.sch002
Section 53 (general interpretation) applies as if—
s.sch002
Section 32 of the Act (powers of entry) applies as...
s.sch002
Section 37 of the Act (appeals to magistrates' court or...
s.sch002
Section 39 of the Act (appeals against improvement notices) applies...
s.sch002
Section 3 of the 1990 Act (presumptions that food intended...
s.sch002
Section 21 of the Act (defence of due diligence) applies...
s.sch002
Section 22 of the Act (defence of publication in the...
s.sch004
Interpretation
s.sch004
Prohibition on the marketing of infant formula or follow-on formula unless certain conditions are met
s.sch004
Restrictions on promotion of infant formula
s.sch004
Application of the improvement notice provisions of the Act
s.sch004
Application of various sections of the Act
s.sch004
Prohibition on the marketing of products other than infant formula for normal healthy infants
s.sch004
Addition of water (infant formula and follow-on formula)
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.