Current UK laws

 
 

Infant formula, follow on formula and infant milks marketed as Foods for Special Medical Purposes

 

EU Delegated acts

Regulations governing the composition and marketing of infant milks changed on the 22nd February 2020 when the retained EU directive Foods for Specific Groups (FSG) (609/2013) which informs UK regulations, came into force and all provisions were fully in force by February 2022.

The directive contains delegated acts. EU delegated regulation 2016/127 relates to infant formula and follow-on formula. EU delegated regulation 2016/128 relates to infant milks marketed as foods for special medical purposes (FSMPs).

The UK has adopted these regulations, so infant formula, follow on formula and infant milks marketed as foods for special medical purposes (FSMPs) manufactured from the 22nd of February 2020 must comply with the new regulations.

It should be noted that the regulations pertain only to composition and marketing, and there are no legal directives relating to the temperature at which powdered infant milks should be reconstituted for safety.

These regulations will remain in force until any alternative regulatory arrangements are made.

UK Statutory Instruments

The Statutory Instruments implementing the EU directives can be accessed here:

 
 
 
 

The regulations related to the marketing and labelling of infant milks (which are the same across the four nations) are summarised here:

 
 
 
 

The DHSC provides guidance about general nutrition legislation in the UK here: Nutrition legislation information sheet - GOV.UK (www.gov.uk). Guidance on Commission Delegated Regulation (EU) 2016/127 (supplementing Regulation EU No 609/2013) is available here.

Milk drinks for children over one year of age

It should be noted that in the UK there are NO specific regulations pertaining to the composition, marketing or labelling of milks marketed for children over 12 months of age (referred to as ‘growing up milks’ and ‘toddler milks’ by manufacturers).

 
 

Department of Health and Social Care Guidance on UK Law

In 2021, the Department of Health and Social Care updated its 2013 guidance on the statutory instruments relating to infant formula and follow on formula. The guidance notes explain the regulations in more detail and are aimed at all companies that manufacture, process, distribute, use, sell or import infant formula and follow-on formula, and those local authorities responsible for enforcing the legislation in this area, as well as being of interest to relevant third sector organisations. 

Whilst the Guidance Notes are non-statutory, given their stated purpose the BFLG believes they are relevant to monitoring company adherence to the law, and for challenging inappropriate marketing and labelling of the regulated products.

 
 

Rationale underpinning UK Law

The UK laws on the composition and marketing of infant formula, follow on formula and infant milks marketed as foods for special medical purposes aims to protect breastfeeding, but also safe and appropriate formula feeding and to ensure that:

  • The essential composition of infant formula and follow-on formula satisfy the nutritional requirements of infants in good health, as established by generally accepted scientific data

  • The labelling allows the proper (safe and adequate) use of such products when necessary, on the basis of adequate information and through appropriate marketing and distribution, and promotes and protects breastfeeding

  • The rules on composition, labelling and advertising are in line with the principles and aims of the International Code of Marketing of Breast-milk Substitutes (‘the Code’) which includes “the provision of safe and adequate nutrition for infants, by the protection and promotion of breastfeeding, and by ensuring the proper use of breast-milk substitutes, when necessary, on the basis of adequate information and through appropriate marketing and distribution”

  • Information provided to carers about infant feeding provides evidence-based and up-to-date information and does not counter the promotion of breastfeeding   

Other main provisions are that:

  • No product other than infant formula may be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal, healthy infants during the first months of life until the introduction of complementary feeding

  • These products shall not contain any substance in such quantity as to endanger the health of infants and young children

  • There are limits on the level of any individual pesticide residue that may be present and specific upper limits for very toxic pesticides

  • There are mandatory and non-mandatory particulars for labelling

  • Requirements are made for the labelling which apply to presentation and advertising

  • No nutrition and health claims can be made in relation to infant formula and infant milks marketed as foods for special medical purposes

  • The labelling, presentation and advertising of infant formula follow-on formula and infant milks marketed as foods for special medical purposes should avoid risk of confusion by the consumer between these three product types

  • There should be restrictions on the advertising of infant formula

Implications of recent infant formula price increases

It is important to note that restricting inappropriate marketing of infant formula does not limit its accessibility. Rather, infant formula becomes inaccessible when its price is unaffordable. See more here. Restricting inappropriate marketing of infant formula does not cause high prices. High prices are largely the result of high profit margins and large marketing budgets. Legal restrictions on infant formula marketing exist to safeguard the health of all babies, however they are fed. Weak legislation on marketing restrictions for breastmilk substitutes and associated products creates loopholes that companies exploit, and this has long been documented in the UK (Save the Children UK, 2007).

 

UK Law enforcement

 
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Regulatory civil servants in the Department of Health and Social Care and The Food Standards Agency, Trading Standards Officers in local authorities, and the Advertising Standards Authority are responsible for handling breaches in UK regulations and relevant codes of practice. 

In theory, the Food Standards Agency works closely with local authorities to investigate complaints via local food safety teams or trading standards officers, depending on what is being reported (their scope of work covers trading practices and product labelling, including claims). The ‘Home Authority Principle’ means that trading standards officers must pass on complaints to officers in the area where the head office of the offending company is based. Primary Authority partnerships mean that Local Authorities and Trading Standards Officers (i.e., those responsible for enforcement of legislation) receive some funding from the same companies that they are responsible for ensuring they enforce the legislation, through direct partnerships.

In practice, however, no systematic and routine monitoring of compliance with the UK legislation takes place, and whilst specific complaints of non-compliance may be addressed, companies are not prosecuted for breaking the law; see the 2024 UNICEF/WHO/IBFAN Code Implementation Status Report.

The Advertising Standards Authority (ASA) deals with complaints relating to broadcast (radio and television) and internet advertising, by referring to their voluntary codes. The ASA is industry funded. It should be noted that the ASA does not accept that violations of the Code and resolutions are breaches of the requirement that advertising be "legal, decent, honest and truthful".

Ofcom (the independent regulator and competition authority for the UK communication industries) also has relevant rules regarding product placement in television programmes, where products that cannot be placed in programmes include "infant formula (baby milk), including follow-on formula". However, such items may be used as props. Companies can be fined for breaking the rules.

 

 Monitoring and reporting violations

 

Given the absence of monitoring and poor enforcement of UK legislation, one way you can take action is by reporting any violations you observe. Baby Milk Action monitors baby food (including breastmilk substitutes) company marketing practices in the UK (in relation to both the UK laws and the Code), on behalf of the Baby Feeding Law Group UK. Please report the details of the observed violation to Baby Milk Action.

Mapping of current UK laws

In June 2022, we completed a Mapping of current UK laws governing the marketing, labelling and safety of breast-milk substitutes, feeding bottles, teats and foods for infants and young children.