Jurisdiction:  EU

Commencement:   direc

Amends:   Regulation (EC) No 1333/2008 on food additives

 

Mini Summary

Regulation (EC) No 1333/2008 on food additives provides a list of approved additives and conditions of their use and labelling. It also simplifies the procedure for the authorisation of food additives.

 

Amendment

In Annex II entries for food category 17, food supplements, are amended, as the previous subcategory, 17.3 ‘food supplements supplied in a syrup type or chewable form’, has been removed. This is due to the sub category leading to misinterpretation causing difficulties with the implementation of Regulation (EC) No. 1333/2008 on food additives.

 

The following amendments have been made as a result:

• The entry for Category 17 in Part D is replaced to reflect the revised subcategories; Part D lists the categories of food that food additives can be added to.
• The entry for Category 17 in Part E is also replaced with entries that were previously in 17.3, transferred into either 17.1 or 17.2. Part E lists the authorised additives for each subcategories and the conditions of use

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Offences and penalties

Criminal offences are introduced for breaches of the main restrictions of The IAS Regulation, as well as offences relating to:

• false statements;
• altering, or not meeting, the conditions of permits and licences;
• attempts to commit offences;
• obstruction; and
• offences for companies and partnerships.

It is also an offence to:

• Allow the escape or release into the wild an animal that is not normally a resident or regular visitor to Great Britain, or an animal listed in Part 1 of Schedule 2, including species of crabs, ducks and squirrel.
• Plant, or allow to grow in the wild, plants listed in Part 2 of Schedule 2.
• Sell, or be involved in the sale of, any plant listed in Part 3 of Schedule 2, including Water Primrose and Floating Pennywort.

These offences aim to act as a deterrent and give regulators the flexibility needed for the most serious breaches.

Offences also relate to any person in, or on, a ship in offshore marine area waters or an offshore marine installation (i.e. an artificial structure, other than a ship, within offshore marine area waters), but not a person on a ship from outside the EU.

If found guilty of an offence a person may be liable to imprisonment of up to 2 years, or a fine. Permits and licences may be made void where an offence is committed and a person may be banned from being granted a permit or licences again for up to 5 years.

Civil penalties are available to allow for proportionate response to minor breaches and are listed in Schedule 3.

Enforcement

Competent authorities in England, Wales, Scotland, and Northern Ireland are:

• the Secretary of State; as well as
• Welsh Ministers / Scottish Minister / Department of Agriculture, Environment, and Rural Affairs (Defra);
• Food Standards Agency / Food Standards Scotland;
• county councils, district / country borough councils; and
• port health authorities (in England and Wales).

 

Enforcement officers and customs officials have the powers to enforce the Order which include:

• stop and search powers;
• powers of entry, including without a warrant at a reasonable time where there are grounds to suspect that a specimen is being kept on the premises;
• powers to seize, examine and take samples; and
• powers to recover costs associated with enforcement.

 

Enforcement of the IAS Regulation at the UK border

Live specimens of invasive species can be seized by Border Force officials. Where this occurs, consignments should be passed to the Animal and Plant Health Agency (APHA) for appropriate handling, e.g. re-export, transfer to appropriate facility, or euthanisation.

Permits

Permits are issued by APHA and the Centre for Environment and Aquaculture Science (CEAS) for aquatic animals.

Permits are issued for import, keeping, and breeding of specimens (but not for sale or release as this is prohibited at all times) in the following cases:

• Research.
• Ex-situ conservation (outside the natural habitat).
• Production and use of products for the advancement of human health.

Where there is an exceptional reason of compelling public interest a permit may be granted for a reason other than those stated above, through the procedure in Article 9 of The IAS Regulation.

Permits are only issued for activities which meet the conditions of Article 8 (2) and (3) of The IAS Regulation, which are detailed in Part 2 of Schedule 1. This includes the requirement for specimens to be kept in contained holdings.

Contained holding means keeping in closed facilities which it is not possible to escape from. Cleaning, waste handling, maintenance, disposal, and culling must be done in a way that reproducible parts can not escape / reproduction cannot occur outside of the holding.

Permits can be revoked or suspended at any time where APHA or CEAS feels there is a risk of negative environmental impact, risk of escape, or spread.

APHA and CEAS may carry out inspections to ensure that conditions of the permit are being met.

Licences

Licenses issued by Natural England and NRW are available for certain otherwise prohibited activities. For example, licences may be granted for:

• Implementation of eradication methods, to ensure rapid eradication at an early stage of invasion (as required by Article 17 of The IAS Regulation).
• Implementation of management measures for IAS that are widely spread (as required by Article 19 of The IAS Regulation).
• Temporary commercial use of an already established IAS as part of management measures to control the population, eradicate or contain the IAS (as allowed by Article 19(2) of The IAS Regulation).
• Keeping and transport of an animal which was previously a pet but has been given to a permitted facility as the owner could not meet the conditions required to keep the animal until the end of its life (as allowed by Article 31(4) of The IAS Regulation).

Licences may be modified, suspended, or revoked at any time.

Reports

The Secretary of State is required to publish a report on a review of the regulatory provisions in this Order and any relevant objectives every 5 years, with the first due by 1st October 2024.

 

 

 

The Food for Specific Groups (Information and Compositional Requirements) (Wales) Regulations 2016

These Regulations enforce Regulation (EU) No. 2016/128 supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for food for special medical purposes (FSMP).

This is the first Regulation that sets out the specific information and compositional requirements for FSMP.

Regulation 2 (interpretation) the following amendments are made:

• A definition of €˜Delegated Regulation is inserted to mean Regulation (EU) No. 2016/128
• A definition of €˜food for special medical purposes is added to have the same meaning as in Regulation (EU) No. 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control , Article 2(g), to ensure consistency.
• The term €˜infant has been defined as a child under the age of 12 months.
• The definition of €˜Specified EU requirement now includes reference to the Delegated Regulation (Regulation (EU) No. 2016/128).
• Paragraph 6 is inserted to make clear that; as this regulation does not cover FSMP for infants, Regulation (EU) No. 2016/128 only applies to FSMP and not FSMP to satisfy the nutritional requirements of infants.

Regulation 7, (Transitional arrangements) is inserted, to introduce a transitional arrangement which allows for stocks of foods not complying with Regulation (EU) No. 2016/128 to be marketed until stocks are exhausted as long as they;

• comply with the specified provisions of Regulation (EU) No. 609/2013;
• Were placed on the market or labelled before 22nd February 2019; and
• meets the requirements of Regulation 3 of the Medical Food (Wales) Regulations 2000, which restricts the sale of medical foods unless the requirements of Directive 1999/21/EC on dietary foods for special medical purposes are complied with.

A new table is inserted into Schedule 1 to ensure consistency with the provision of the EU Regulations. References to Regulation (EU) No. 2016/128 in Schedule 1 should be read as the most up to date version as amended.

The Medical Food (Wales) Regulations 2000

An amendment is made to Regulation 2 (interpretation) to make clear that this Regulation only covers Food for Special Medical Purposes (FSMP) for infants by including the phrase €˜developed to satisfy the nutritional requirements of infants, into the definition of medical food.

Other FSMPs are covered by The Food for Specific Groups (Information and Compositional Requirements) (Wales) Regulations 2016

 

 

 

 

Jurisdiction:  Northern Ireland

Commencement:   22nd February 2019

Amends:  

1. The Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016
2. The Medical Food Regulations (Northern Ireland) 2000

 

Mini Summary

These Regulations provide for the enforcement, in Northern Ireland, of:

• Regulation (EU) No. 2016/128, supplementing Regulations (EU) No. 609/2013 as regards the specific compositional and information requirements for food for special medical purposes; and
• Regulation (EU) No. 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.

Regulation (EU) No. 2016/128 is the first Regulation that sets out the specific information and compositional requirements for Food for Special Medical Purposes (FSMP)

Regulation (EU) No. 609/2013 sets out the general rules for governing the composition and labelling requirements for certain categories of food.

These Regulations provide for the enforcement of those requirements by applying certain provisions of the Food Safety (Northern Ireland) Order 1991

 

Duties

These Regulations enforce the following Articles of Regulations (EU) No. 2016/128 and their requirements;

Article 2(2) (requirement for the formulation of food to be based on sound medical and nutritional principles)

Requires the formulation of FSMP to be based on sound medical and nutritional principles, used in accordance within the manufacturer’s instructions and meeting the specific nutritional requirements for who it is intended for.

Article 3(2) (requirement relating to residue levels)

FSMPs to satisfy the nutritional requirements of young children shall not contain residue levels exceeding 0.01 mg/kg per active substance. Active substances are referred to micro-organisms having general or specific action against harmful organisms.

Article 3(4) (prohibition on the use of plant protection products)

FSMP to satisfy the nutritional requirements of young children shall not contain any agricultural products which have been produced using plant protection products (pesticides etc.) which contain any of the active substances listed in Annex III.

Article 4 (name of the the food)

The name of a FSMP shall be set out in accordance with Annex IV

Article 5(2) (specific requirements on food information)

This lists the statements that must be included on the labels of FSMPs

Article 6 (specific requirements on food information)

Declaring the nutritional information is mandatory for all FSMPs irrespective of the size of the container or packaging it is places in.

Article 7 (nutrition and health claims)

There shall be no nutrition and health claims on FSMPs

Article 9 (notification requirement)

When a FSMP is placed on the market, the food business operator must notify the district council where the product is being marketed and is to send a label containing all the information appearing on the product.

 

Amendments

The Food Safety (Information and Compositional Requirements) (Amendment) Regulations (Northern Ireland) 2016

These Regulations make provision to enforce Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for food for special medical purposes

This is the first Regulation that sets out the specific information and compositional requirements for FSMP

In Regulation 2 (interpretation) several amendments are made:

• A definition of ‘Delegated Regulation’ is inserted to mean Regulation (EU) No. 2016/128
• A definition of ‘food for special medical purposes’  is added to have the same meaning as in Regulation (EU) No. 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control, Article 2(g), to ensure consistency.
• The phrase ‘infant’ has been defined as a child under the age of 12 months.
• The definition of ‘Specified EU requirement’ now includes reference to Regulation (EU) No. 2016/128 which is referred to as the Delegated Regulation.
• Paragraph 5 is inserted to make clear that these Regulations do not cover FSMP for infants and Regulation (EU) No. 2016/128 only applies to FSMP and not FSMP to satisfy the nutritional requirements of infants.

Regulation 8 (Transitional Arrangements) is inserted, to introduce a transitional arrangement which allows for stocks of food not complying with Regulation (EU) No. 2016/128 to be marketed until stocks are exhausted as long as;

• They comply with the specified provisions of Regulation (EU) No. 609/2013;
• It was placed on the market or labelled before 22nd February 2019; and
• It meets the requirements of Regulation 3 of the Medical Food Regulations (Northern Ireland) 2000, which restricts the sale of medical foods unless the requirements of Directive 1999/21/EC on dietary foods for special medical purposes are complied with.

A new table is inserted into Schedule 1, to ensure consistency with the provision of the EU Regulations. References to Regulation (EU) No. 2016/128 in Schedule 1 should be read as the most up to date version as amended.

 

The Medical Food Regulations (Northern Ireland) 2000

An amendment is made to Regulation 2 (interpretation) to make clear that this Regulation only covers Food for Special Medical Purposes (FSMP) for infants by including the phrase ‘ developed to satisfy the nutritional requirements of infants’ into the definition of medical food.

Other FSMPs are covered by The Food Safety (Information and Compositional Requirements) Regulations (Northern Ireland) 2016

 

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