Guidance on the Requirements

of Article 15 of Regulation
178/2002 of 28 January 2002
Laying Down the General
Principles and Requirements of
Food Law
For all queries about this guidance — including if you require the
information in an alternative format such as audio, large print or
Braille — please use the number below.

Animal Feed and Animal By-Products Branch

020 7276 8462

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 Summary

Intended audience:  Farmers and growers

 Importers
 Manufacturers and processors
Which UK nations All UK nations.
does this cover?
Purpose: To provide advice on the provisions of Article 15, which
concerns feed safety.
Legal status: This note provides an interpretation of the provisions of
Article 15 but is not itself a guide to compliance with it, as
the exact circumstances in which the law is required to be
applied will depend on the nature of the feed safety breach.
Key words  Additives and supplements
 Animal feed
 Arable farming
 Contaminants and food contact materials
 Dairy products and vegetable oils
 Food law, monitoring and controls
 Hygiene and food safety
 Imports
Review date This note is current. It will only need to be reviewed if the
legislation to which it relates is itself amended.
Sunset date The EU legislation in question has no sunset clause.

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REVISION HISTORY

This guidance follows the Government Code of Practice on Guidance. If you believe this
guidance breaches the Code for any reason, please let us know by emailing
betterregulation@[Link]. If you have any comments on the guidance
itself, please call us using the contact number on page 2 or complete our ongoing Guidance
survey: [Link]

Revision Revision date Purpose of revision and Revised by

No. paragraph number
2 November 2012 Updating of contact details Joseph Nicholas
3 March 2014 Updating of contact details Joseph Nicholas

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CONTENTS

REVISION HISTORY ................................................................................................. 4

CONTENTS ............................................................................................................... 5
INTRODUCTION ........................................................................................................ 6
INTENDED AUDIENCE ............................................................................................. 6
PURPOSE OF GUIDANCE ........................................................................................ 6
LEGAL STATUS OF GUIDANCE .............................................................................. 7
THE GUIDANCE ........................................................................................................ 7
NATIONAL LEGISLATION ........................................................................................ 9
CONTACTS................................................................................................................ 9

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INTRODUCTION

1. EU Regulation 178/2002 of 28 January 2002 established the European Food

Safety Authority, laid down the general principles and requirements of food law, and
laid down procedures in matters of food safety. It came into force on 21 February
2002, although certain key provisions did not apply until 1 January 2005. The
principal aim of the Regulation is to protect human health and consumer interests in
relation to food while at the same time improving the functioning of the EU market for
food and feed.

2. For the purposes of the Regulation, food law includes feed produced for or fed
to both food-producing and non-food-producing animals (i.e. both farmed livestock
and other animals such as pets, game, and zoo, circus and laboratory animals). It
therefore applies to all stages of the production, processing and distribution of feed,
subject to certain exemptions for primary production for private domestic use.

INTENDED AUDIENCE

3. This note is intended for the use of enforcement authorities and feed business
operators -- i.e., primary producers of commodity crops, importers, merchants, feed
compounders, food businesses supplying product into the animal feed chain, hauliers
transporting feed, on-farm growers and users of feed, and producers of feed for pets
and other non-food-producing animals. All feed businesses covered by Regulation
178/2002 must comply with the requirements of Article 15. There are no exceptions
for small and medium-sized enterprises.

PURPOSE OF GUIDANCE

4. Guidance on the interpretation and implementation of Articles 11-12 and 16-20

of Regulation 178/2002 was adopted by the Standing Committee on the Food Chain
and Animal Health on 20 December 2004. (Article 19 concerns the recall and
withdrawal of unsafe food.) This guidance is available on the Commission's website
at [Link]

5. The Commission's guidance does not cover Article 15, which is the subject of
this note. As this guidance is intended to supplement the Commission's and not to
substitute for it, it does not address the other feed-related Articles of the Regulation.

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LEGAL STATUS OF GUIDANCE

6. This guidance note has been produced to explain the legal requirements of
Article 15 of Regulation 178/2002 on the general principles of food law (which
includes feed law). However, it cannot cover every situation and stakeholders may
need to consider the legislation itself to see how it applies in their particular
circumstances. If this guidance note is followed it will help stakeholders comply with
the law. Businesses with specific queries may wish to seek the advice of their local
enforcement authority, which in Great Britain will usually be the trading standards
department of the local authority and in Northern Ireland is the Department of
Agriculture and Rural Development.

THE GUIDANCE

7. The feed-related Articles of EU Regulation 178/2002 impose a number of

responsibilities on feed business operators, as follows:
 feed imported from or exported to a third country must comply with the
requirements of EU feed law (Articles 11 and 12);
 feed must not be unsafe, i.e. it must not have an adverse effect on human
or animal health, or make animal products (milk, meat and eggs) unsafe for
human consumption (Article 15);
 the labelling, advertising and presentation of feed must not mislead
consumers (Article 16);
 feed business operators must ensure that all stages of their operations
satisfy those requirements of feed law which apply to them (Article 17);
 feed business operators must be able to identify any individuals or
businesses from which they have obtained food-producing animals, feed or
feed ingredients and the businesses to which they have supplied products,
and be able to produce this information on demand (Article 18);
 feed business operators must withdraw unsafe feed from sale, or recall it
from purchasers if it has already been sold (Article 20); and
 feed business operators must inform the competent authorities of the
action they are taking and collaborate with action taken by the competent
authorities (also Article 20).

8. A feed business operator is defined as "the natural or legal person responsible

for ensuring that the requirements of food law are met within the feed business under
their control". A feed business is defined as "any undertaking, whether for profit or
not whether public or private, carrying out any operation of production, manufacture,
processing, storage, transport or distribution of feed including any producer
producing, processing or storing feed for feeding to animals on his own holding".
These requirements therefore apply to a wide range of undertakings, including
primary producers of commodity crops, importers, merchants, feed compounders,

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food businesses supplying product into the animal feed chain, and producers of feed
for pets and other non-food-producing animals.

9. Feed must not be marketed or fed to animals if it is unsafe. In this context,

unsafe means that it is considered to have an adverse effect on animal or human
health, or that it is considered to make the food derived from food-producing animals
unsafe for human consumption. In those cases where a feed identified as unsafe is
part of a larger consignment of the same feed product, then all of the consignment
will be considered unsafe unless evidence is produced that the rest of it satisfies EC
feed safety requirements. These requirements apply equally to one-off sales and to
feed supplied free of charge.

10. Feed can be rendered unsafe in several ways -- for example by contamination,
by the presence of foreign objects, by deterioration due to age or decomposition.
Once a feed business operator has identified an unsafe feed, or a hazard which may
potentially have made the feed unsafe, a risk assessment should be carried out. The
nature of the risk assessment will depend on a variety of factors, such as the nature
and intended use of the feed product, the age and species of the animals which may
have consumed it, and the nature of the safety breach. The risk assessment should
nevertheless attempt to address two key questions: the harm which might be caused;
and the likelihood of that harm. The action to then be taken -- for example to control
the hazard, withdraw the feed, monitor its use -- will depend on the outcome of the
risk assessment.

11. Feed will be deemed to be safe in so far as it complies with the provisions laid
down in EC feed legislation -- for example, it does not contain levels of undesirable
substances above those specified, it does not contain any prohibited ingredients, or
the specified maximum inclusion rates for permitted additives are not exceeded.
However, this will not in itself prevent the enforcement authority from placing
restrictions on feed which complies with specific EC-derived feed legislation if they
have grounds for believing that it may be unsafe for other reasons -- for example,
deterioration due to age or decomposition, or high levels of a particular contaminant
which (although there may be no maximum permitted level for it laid down in feed
legislation) may potentially have an adverse effect on animal or human health.

12. In the absence of any specific EC provisions on aspects of feed safety, feed
will be deemed to be safe if it complies with any national requirements, provided that
these requirements have been drawn up in accordance with Articles 28 and 30 of the
Treaty establishing the European Community. However, as is the case with EC
legislation, the fact that a feed may be deemed to be safe if it complies with national
provisions does not prevent enforcement officials taking action if they consider the
feed to be unsafe despite complying with specific legislation.

13. Articles 28 and 30 prohibit quantitative restrictions on imports, or measures

having an equivalent effect, except where "justified on grounds of public morality,
public policy or public security; the protection of health and life of humans, animals or

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plants; the protection of national treasures possessing artistic, historic or
archaeological value; or the protection of industrial and commercial property". In
practice it might be very difficult to produce a justification which would be acceptable
to the European Court of Justice, but in any case the UK has no national feed safety
requirements over and above those laid down in EU feed law.

NATIONAL LEGISLATION

14. EU Regulations are directly applicable in all Member States but in order to give
them effect in the UK it is necessary to provide for their enforcement by designated
authorities. For the feed-related Articles of Regulation 178/2002, this was achieved
by regulation 15 of the Feed (Hygiene and Enforcement) Regulations 2005.

15. There is separate but parallel legislation in each of the four countries of the
UK. The full titles and numbers of this legislation are as follows:
 The Feed (Hygiene and Enforcement) (England) Regulations 2005 (S.I.
2005 No. 3280)
 The Feed (Hygiene and Enforcement) (Wales) Regulations 2005 (S.I.
2005 No. 3368) (W 265)
 The Feed (Hygiene and Enforcement) (Scotland) Regulations 2005 (S.S.I.
2005 No. 608)
 The Feed (Hygiene and Enforcement) Regulations (Northern Ireland) 2005
(S.R. 2005 No. 546)

16. These Regulations can be found online at:

[Link] (enter the year and number of the measure in
the search boxes at the top of the page and select the type of legislation from the
drop-down box alongside). EU Regulation 178/2002 can be found online at:
[Link]
OJ:L:2002:031:0001:0024:EN:PDF Details of other animal feed legislation can be
found on the Food Standards Agency’s website at [Link]
industry/farmingfood/animalfeed/animalfeedlegislation/

CONTACTS

England -- Animal Feed and Animal By-Products Branch: William Francis, telephone
020 7276 8471, e-mail <[Link]@[Link]>.

Wales -- Food Policy: Hilary Neathey, telephone 029 2067 8911, e-mail
<[Link]@[Link]>.

Scotland -- General Food and Feed Safety and Hygiene: Claire Moni, telephone
01224 285158, e-mail <[Link]@[Link]> or Feed Law

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Enforcement: Jacqui Angus, telephone 01224 285175, e-mail
<[Link]@[Link]>.

Northern Ireland -- Primary Production Unit: Anthony Higgins, telephone 028 9041
7761, e-mail <[Link]@[Link]>; or Gerard Smyth,
telephone 028 9041 7760, e-mail <[Link]@[Link]>.

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