Listed substances and their purity criteria (infant formula and follow-on formula)
- Use only listed substances meeting purity criteria in infant formula manufacture Any Person
Scottish Statutory Instrument
2020
Scotland
The Foods for Specific Groups (Infant Formula and Follow-on Formula) (Scotland) Regulations 2020
These Regulations, which extend to Scotland only, make provision to enforce Commission Delegated Regulation (EU) 2016/127 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (“the Delegated Regulation”).
At a glance
Enforced by
What's here
20 compliance obligations
Penalty landscape
6 of 20 obligations carry a criminal penalty. 1 carries different penalties and 13 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 14
- 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
Notification of infant formula
- Notify Food Standards Scotland before placing new infant formula on the Scottish market Operator
Pesticide residues (infant formula and follow-on formula)
- Ensure infant formula and follow-on formula meet strict pesticide residue limits Manufacturer
Naming of infant formula
- Only sell your product 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
- Ensure infant formula labelling meets all legal requirements Any Person
Labelling of follow-on formula
- Ensure follow-on formula labelling meets mandatory requirements Any Person
Presentation (infant formula and follow-on formula)
- Ensure presentation of infant formula and follow-on formula complies with legal rules Any Person
Prohibition on the marketing of infant formula or follow-on formula unless certain conditions are met
- Market infant or follow-on formula without meeting required conditions Any Person
Restrictions on advertising infant formula
- Advertise infant formula without following legal restrictions Any Person
Restrictions on advertising follow-on formula
- Advertise follow-on formula in breach of restrictions Any Person
Restrictions on promotion of infant formula
- Promote infant formula in prohibited ways Manufacturer
Provision of informational and educational material dealing with the feeding of infants
- Produce non-compliant infant feeding materials or make improper donations Manufacturer
Offences and enforcement
Unlimited fine- Fail to comply with infant formula marketing or labelling rules Any Person
Prohibition on the marketing of products other than infant formula for normal healthy infants
- Market non-infant formula as suitable for young infants Any Person
Substances in such quantity as to endanger the health of infants and young children
- Ensure infant formula contains no harmful substances Any Person
Protein hydrolysates and other food ingredients suitable for infants from birth (infant formula)
- Prove suitability of protein hydrolysates and other ingredients in infant formula Any Person
Protein hydrolysates and other food ingredients suitable for infants aged over six months (follow-on formula)
- Manufacture follow-on formula only from approved protein hydrolysates and other proven ingredients Manufacturer
Compositional criteria for infant formula
- Ensure infant formula meets compositional criteria and, for certain protein hydrolysates, conduct suitability studies Any Person
Compositional criteria for follow-on formula
- Ensure follow-on formula meets compositional and nutritional study requirements Manufacturer
Browse 6 other Schedules — structural / supplementary
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
Free or reduced rate infant formula
Application of various sections of the Food Safety Act 1990
Addition of water (infant formula and follow-on formula)
Browse 7 other sections — procedural / definitional / commencement
Citation, commencement and extent
Interpretation
Enforcement
Offences and penalties
Application of provisions of the Act
Revocations, savings and transitional provisions
Consequential amendment
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
Food safety and standards in Scotland. Independent public body with similar remit to FSA but for Scotland specifically. Administers Food Hygiene Information …
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Regulators
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