Current UK Laws for infant formula and follow on formula

 

The UK laws which currently apply to the composition, marketing and safety of infant formula and follow on formula within the UK are:

It should be noted that while the legislation is devolved, the content of each nation’s statutory instruments is identical to the regulations for England. For reference see:

Welsh statutory instruments

Scottish statutory instruments

Northern Irish statutory instruments

These laws are the result of EU Commission Directive 2006/141/EC (which sits under the 2009/39/EC European Framework directive on ‘Foods for Particular Nutritional Uses’), which required member states of the European Union to adopt and publish, by 31 December 2007 at the latest, laws and administrative provisions to implement the Directive at a national level.

In 2013, the Department of Health updated its guidance on the rules in these statutory instruments, see more below.

 

Regulations on infant formula and follow on formula due to become mandatory in 2020: an update

In 2016, the framework directive under which EU Commission Directive 2006/141/EC sat, and which informed the statutory instruments shared above, was replaced by new EU Regulations on ‘Foods for Specific Groups’ (FSG) (609/2013). Accordingly, and before the prospect of Britain leaving the EU, directive 2006/141/EC was due to be replaced by a new commission delegated regulation on infant formula and follow on formula: EU 2016/217. Whilst the FSG directive has been in force since July 2016, companies were given up to four years to make changes in line with the delegated acts. This means that while companies can currently sell infant formula and follow on formula which are compliant with either the previous or the new regulations, the new regulations are only due to be mandatory from the 22nd of February 2020. The exception to this are infant formulas and follow on formulas manufactured from protein hydrolysates, to which it is meant to apply from 22nd February 2021.

We will endeavour to provide updates on the implications to current regulations that arise from Britain’s exit from the EU


 

Current regulations for Foods for Special Medical Purposes

The other UK law which currently applies to the marketing and safety of infant milks marketed as ‘Foods for Special Medical Purposes’ (FSMP) is:

 As for the infant formula and follow on formula regulations, while the legislation is devolved, the content of each nation’s statutory instruments is identical to the regulations for England. For reference see:

Welsh statutory instruments

Scottish statutory instruments

Northern Irish statutory instruments

These rules cover the composition and labelling of foods intended for the dietary management (under medical supervision) of individuals who suffer from certain diseases, disorders or medical conditions. They were laid down by the Commission Directive 1999/21/EC, and adopted under the framework Directive 2009/39/EC.

 

Regulations on infant milks marketed as ‘Foods for Special Medical Purposes’ due to become mandatory in 2020: an update

As for infant formula and follow on formula, Directive 1999/21/EC was also replaced under the delegated act from the Foods for Specific Groups legislation (609/2013) mentioned above. The new Commission delegated Regulation is (EU) 2016/128, which was adopted on the 25th September 2015 and is meant to be mandatory from the 22nd of February 2020. Until that date, the rules of Directive 1999/21/EC are meant to remain applicable.

We will endeavour to provide updates on the implications to current regulations that arise from Britain’s exit from the EU


 

Department of Health Guidance on UK Laws

In 2013, the Department of Health updated its guidance on the rules in these statutory instruments relating to infant formula and follow on formula, in association with the Welsh Government, and Food Standards Agency in Scotland and Northern Ireland. This guidance therefore applies across the UK. The guidance notes explain the existing 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 who are responsible for enforcing the legislation in this area.

 

 

Rationale underpinning UK Law

The UK laws aim 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 of infant formula and follow-on formula allows the proper use of such products 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’)

  • Information provided to carers about infant feeding 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

  • Infant formula and follow-on formula shall not contain any substance in such quantity as to endanger the health of infants and young children

  • There are detailed requirements for the essential composition of infant formula and follow-on formula

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

  • There are mandatory and non-mandatory particulars for the labelling of infant formula and follow-on formula

  • Requirements are made for the labelling of infant formula and follow-on formula to apply to presentation and advertising

  • There are restrictions on nutrition and health claims that can be made in relation to infant formula

  • The labelling, presentation and advertising of infant formula and follow-on formula should avoid risk of confusion by the consumer between these two products

  • There should be restrictions on the advertising of infant formula

 

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.

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.

You can share your observations of violations of both UK laws and the Code with Baby Milk Action and/or make your complaint on violations of the UK law to the relevant regulatory bodies described above. Find out more here.