ANNEXE B

Title:
Consolidation of English national law for food safety and food
Impact Assessment (IA)
hygiene in the draft Food Safety and Hygiene (England) Date: 02/09/2013
Regulations 2013
Stage: Consultation
IA No: FOOD0112 Source of intervention: EU
Lead department or agency: Type of measure: Secondary legislation
Food Standards Agency Contact for enquiries:
Other departments or agencies: David Gray
020 7276 8940 (direct line):
david.gray@foodstandards.gsi.gov.uk
Summary: Intervention and Options RPC Opinion: RPC Opinion Status
Cost of Preferred (or more likely) Option
Total Net Present Business Net Net cost to business per In scope of One-In, Measure qualifies as
Value Present Value year (EANCB on 2009 prices) Two-Out?
£m £1.51 £m -£0.17 £m- £0.16 No In/Out/zero net cost
What is the problem under consideration? Why is government intervention necessary?
Food businesses raised concerns that it was difficult to locate legislation that affected them because it was
not all in one place.
What are the policy objectives and the intended effects?
The consolidation into one Statutory Instrument (SI) for England of the provisions of the General Food
Regulations 2004 (as amended) and the Food Hygiene (England) Regulations 2006 (as amended) that
enforce European Union (EU) cross-sectoral food safety and food hygiene requirements will make it easier
for food businesses to find food safety and food hygiene legal requirements relevant to them. The
consolidation is one element of the FSA’s work under the Red Tape Challenge to introduce a simplified
system of national food safety legislation.
The consolidation will also result in the legislation being brought up-to-date, with the benefit of greater clarity
for food businesses and enforcers but does not introduce changes to what businesses are required to do.

The legislation being consolidated contains existing national rules. These are being reviewed separately so
as not to hold up the consolidation and delay the benefits.
What policy options have been considered, including any alternatives to regulation? Please justify preferred
option (further details in Evidence Base)
Option 1. Do nothing - rejected as this would mean that any potential benefits resulting from the proposed
consolidation could not be taken up.
Option 2. Proceed with the consolidation of the General Food Hygiene Regulations 2004 and the Food
Hygiene (England) Regulations 2006. This is the preferred option.

A third option of replacing the legislation with guidance was considered, but rejected as EU law requires EU
Member States to provide national legislation to enforce EU requirements. Further detail can be found at
Appendix B.
Will the policy be reviewed? It will be reviewed. If applicable, set review date: 11/2018
Does implementation go beyond minimum EU requirements? Yes
Are any of these organisations in scope? If Micros not Micro < 20 Small Medium Large
exempted set out reason in Evidence Base. Yes Yes Yes Yes Yes
What is the CO2 equivalent change in greenhouse gas emissions? Traded: Non-traded:
(Million tonnes CO2 equivalent) N/A N/A
I have read the Impact Assessment and I am satisfied that, given the available evidence, it represents a
reasonable view of the likely costs, benefits and impact of the leading options.

Signed by the responsible Chief Executive: Date:

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 ANNEXE B
Summary: Analysis & Evidence Policy Option 1
Description: Do nothing
FULL ECONOMIC ASSESSMENT
Price Base PV Base Time Period Net Benefit (Present Value (PV)) (£m)
Year 2013 Year 2013 Years 10 Low: Optional High: Optional Best Estimate: N/A

COSTS (£m) Total Transition Average Annual Total Cost

(Constant Price) Years (excl. Transition) (Constant Price) (Present Value)
Low Optional Optional Optional
High Optional Optional Optional
Best Estimate N/A N/A N/A
Description and scale of key monetised costs by ‘main affected groups’
There are no monetised incremental costs or benefits associated with this option. This is the baseline
against which other options are assessed.

Other key non-monetised costs by ‘main affected groups’

There are no non-monetised incremental costs or benefits associated with this option. This is the baseline
against which other options are assessed.

BENEFITS (£m) Total Transition Average Annual Total Benefit

(Constant Price) Years (excl. Transition) (Constant Price) (Present Value)
Low Optional Optional Optional
High Optional Optional Optional
Best Estimate N/A N/A N/A
Description and scale of key monetised benefits by ‘main affected groups’
There are no non-monetised incremental costs or benefits associated with this option. This is the baseline
against which other options are assessed.

Other key non-monetised benefits by ‘main affected groups’

There are no non-monetised incremental costs or benefits associated with this option. This is the baseline
against which other options are assessed.

Key assumptions/sensitivities/risks Discount rate (%) 3.5

Any potential benefits resulting from the proposed consolidation could not be taken up.

BUSINESS ASSESSMENT (Option 1)

Direct impact on business (Equivalent Annual) £m: In scope of OITO? Measure qualifies as
Costs: N/A Benefits: N/A Net: N/A No IN/OUT/Zero net cost

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 ANNEXE B
Summary: Analysis & Evidence Policy Option 2
Description: Proceed with the consolidation of the General Food Hygiene Regulations 2004 and the Food Hygiene
(England) Regulations 2006.
FULL ECONOMIC ASSESSMENT
Price Base PV Base Time Period Net Benefit (Present Value (PV)) (£m)
Year 2013 Year 2013 Years 10 Low: Optional High: Optional Best Estimate: £1.5

COSTS (£m) Total Transition Average Annual Total Cost

(Constant Price) Years (excl. Transition) (Constant Price) (Present Value)
Low Optional Optional Optional
High Optional Optional Optional
Best Estimate £0 £0 £0
Description and scale of key monetised costs by ‘main affected groups’
We do not envisage any substantial costs from the proposed consolidation.

Other key non-monetised costs by ‘main affected groups’

We do not envisage any substantial costs from the consolidation.

BENEFITS (£m) Total Transition Average Annual Total Benefit

(Constant Price) Years (excl. Transition) (Constant Price) (Present Value)
Low Optional Optional Optional
High Optional Optional Optional
Best Estimate £0 £0.17 £1.5
Description and scale of key monetised benefits by ‘main affected groups’
We have estimated an indicative annual benefit to new entrants of £174, 870, a total benefit of £1.5m over
10 years from the consolidation of the legislation.

Other key non-monetised benefits by ‘main affected groups’

We envisage there will be benefits to enforcement officers from the simplification of the legislation but we
have been unable to monetise these.

Key assumptions/sensitivities/risks Discount rate (%) 3.5

BUSINESS ASSESSMENT (Option 2)

Direct impact on business (Equivalent Annual) £m: In scope of OITO? Measure qualifies as
Costs: £0 Benefits: £0.17 Net: -£0.17 No IN/OUT/Zero net cost

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Evidence Base (for summary sheets)

Problem under consideration/rationale for intervention

1. Concerns have been raised by food businesses that it can be difficult to find food safety and food
hygiene law relevant to them. Furthermore, the national legislative provisions concerned are a few
years old and there are several amending SIs. This is an opportunity therefore to update the
provisions and consolidate the amendments together without altering the requirements on
businesses.
2. Intervention will result in legislation that is more accessible for affected businesses and clearer and
more usable for both enforcers and food businesses.

Policy objective
3. The objective is to make it easier for food businesses to find national food safety and food hygiene
legal requirements relevant to them. The proposed consolidation will also result in the legislation
being brought up to date providing greater clarity for food businesses and enforcers. There are no
changes to what businesses are required to do. The legislation applies to all food businesses.
4. The Food Hygiene (England) Regulations 2006 contain national rules on temperature control for
retail businesses and on raw drinking milk. These rules are being reviewed separately and will take
some time to complete. In the meantime, the consolidation will take these rules forward unchanged
so that the benefits of the consolidation are not delayed.

Background: English national legislation and the proposed consolidation

Current national legislation in England – brief description

5. Currently, in England, the EU Regulations (described in Appendix A) are given effect by and
enforced through two Statutory Instruments (SIs) and their amendments. These are:
• The General Food Hygiene Regulations 20041 which enforce the requirements found in
Regulation (EC) 178/2002, specifically with regard to the requirement to place safe food
on the market, the presentation of food and labelling and other responsibilities for
businesses such as the recall of food believed to be unsafe; and
• The Food Hygiene (England) Regulations 2006 which enforce the hygiene requirements
placed on food businesses. They set out provisions which include the enforcement
actions that can be taken and the circumstances in which they can be taken; the way in
which food samples are procured; the powers of entry; offences and penalties; the due
diligence defence and rights of appeal. These also contain national rules as described in
paragraph 4.
Other rules being introduced in the consolidated SI
6. The provision of national legislation giving effect to and providing enforcement for recent EU
regulations on sprouted seeds2. The expected impacts of these measures are covered in a separate
Impact Assessment3.
7. The Food Safety (Sampling & Qualifications) Regulations 2013 came into force on 6th April 2013.
These regulations specify the qualifications necessary to be a public analyst, food analyst or food
examiner for the purposes of the Food Safety Act 1990. Following feedback from stakeholders it is
considered necessary to amend the regulations to make a current qualification to be a food
examiner more fit for purpose and this amendment is included in the proposed consolidated SI.
Therefore the qualification listed in Schedule 2, Part 1 (5) “Fellowship or Membership of the Institute
of Food Science and Technology” will be amended to include membership of the IFST Food

1
These regulations also enforce food safety rules in Scotland and Wales. The consolidated SI will take up the provisions as they apply to
England.
2
These are: Regulation (EU) No 208/2013, 209/2013, 210/2013 and 211/2013.
3
The IA (no.0122 ) is included in the consultation package issued 02.09.2013 with this IA.
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 Microbiology Group. The updated qualification will read “Fellowship or Membership of the Institute of
Food Science and Technology together with membership of its Professional Food Microbiology
Group.” The impact of the Food Safety (Sampling & Qualifications) Regulations 2013 was the
subject of a separate IA4

The proposed consolidated English national legislation

8. The title of the draft SI is the Food Safety and Hygiene (England) Regulations 2013. Effectively the
draft SI uses the format/layout of the Food Hygiene (England) Regulations 2006 ‘inserting’ the
relevant provisions of the General Food Hygiene Regulations 20045.
9. Specific features of the proposed consolidated SI, set out in the order they appear in the SI, are:
I. The “Community Regulations” have been redefined as the “EU Hygiene Regulations”, which
do not include Regulation (EC) 178/2002.
II. Regulation 4 now deals with competent authorities for the purposes of Regulation (EC)
178/2002 as well as the EU Hygiene Regulations.
III. New paragraphs (6) to (8) have been inserted in regulation 5 to address enforcement of
Regulation (EC) 178/2002.
IV. For the purposes of clarity, the provisions for Remedial Action Notices (RANs) and Detention
Notices (together in regulation 9 of The Food Hygiene (England) Regulations 2006) have
been split into two separate regulations (regulations 9 and 10) in the new SI.
V. For purposes of clarity, at regulations 9 and 10 the phrase “an establishment that Article 4(2)
of Regulation 853/2004 requires to be approved” has replaced the current 6 drafting
formulation. While it was always the intention that these notices can also be used in
establishments that should be approved but are not, it has been suggested that this could be
made more explicit. This clarification does not extend the use of RANs to food business
premises that do not require approval.
VI. At regulation 15(11), “food authority” has been changed to “enforcement authority” for the
sake of consistency with regulation 14 and the rest of 15.
VII. Regulation 36 contains a consequential amendment to The Food Safety Act 1990 as
previously amended by The General Food Regulations 2004. It ensures the link between the
seize and detain powers of the Act and the enforcement of Regulation 178/2002 as regards
the placing of unsafe food on the market.
VIII. Regulation 37 amends The Official Feed and Food Controls (England) Regulations 2006 (as
amended) and contains new provisions enforcing the new EU regulations as regards imports
of sprouts and seeds intended for sprouting
IX. Consequential amendments may have to be finalised after consultation, since some of them
concern SIs that are in the throes of being revised by Defra and which may or may not have
been re-made by the time the new proposed Regulations are due to come into force.
X. In Schedule 2 the relevant provisions of 178/2002 have been added so as to link in to the
existing enforcement structure carried forward from the Food Hygiene (England) Regulations
2006 by reference to “specified EU provisions” as defined in regulation 2.
XI. Schedules 3A to 3D in the Food Hygiene (England) Regulations 2006 have been grouped
together as Schedule 7 in the new SI, divided into 4 Parts.

XII. Schedule 9 lists the revocations made by the SI.

Q1: Do stakeholders agree that the new wording removes the ambiguity described in V above?

4
http://food.gov.uk/multimedia/pdfs/enforcement/ia-safety-sampling.pdf
5
Provisions of these Regulations that amend the Food Safety Act 1990 will be left unrevoked in the 2004 SI and not carried over into the new
proposed consolidated Regulations.
6
“in respect of an establishment subject to approval”
5
Q2: Do stakeholders agree with the proposed drafting changes listed above? Are there any other
changes that should be made?

Enforcement provisions

Powers of entry
10. Between them The General Food Hygiene Regulations 2004 (as amended) and The Food Hygiene
(England) Regulations 2006 (as amended) contain four powers of entry which will be reduced to
three by the proposed consolidation. More detail can be found at paragraphs 36-38.

Criminal offences
11. The number of offences has been reduced. More detail can be found at paragraph 39.

Rationalisation of fines
12. In bringing together the provisions of the two principal SIs, there does not appear to be a good
reason for having a difference in the treatment of serious food safety offences and food hygiene
offences, which will be inextricably linked in many cases.
13. That being the case, it is proposed not to replicate in the new SI the provision in the General Food
Regulations 2004 whereby an offence contravening Article 14 of Regulation (EC) 178/2002 is
punishable on summary conviction by fine of the “relevant amount” (i.e. a maximum of £20,000 ).
This is because the £20,000 figure is considerably higher than the usual level 5 (£5,000 currently)
for summary offences, as is found in regulation 17 of the Food Hygiene (England) Regulations 2006.
14. For any given food safety or food hygiene offence the proposed rationalisation will not result in a
change to the maximum levels of available fines. However, it will mean that fines above Level 5
(currently £5, 000) will only be able to be imposed by a Crown Court. Magistrates will be able to
impose fines up to Level 5 and will have the option of referring matters to the Crown Court for
sentencing where they feel that the penalty should exceed that level. The Crown Court, as now, will
be able to impose a penalty of up to 2 years imprisonment and /or an unlimited fine.
Q3: Do stakeholders agree that the equalisation of fines as described is appropriate and that the
proper level of deterrent remains to prevent the supply of unsafe food or the supply of food in a
way that is against consumers’ interests?

Due diligence defence

15. At regulation 12 of the draft SI the ‘due diligence’ defence set out in Section 21 of The Food Safety
Act 1990 and applicable to certain offences under the Act is applied for the purposes of the
consolidated SI and adapted for the purposes of offences of breaching certain Articles of Regulation
(EC) 178/2002. ‘Due diligence’7 is a defence designed to balance the protection of the consumer
against defective food with the right of traders not to be convicted of an offence they have taken all
reasonable care to avoid committing. A defence relevant to exports is set out at regulation 13.

Description of options considered (including do nothing)

16. The following options have been considered. Option 2 is preferred.

Option 1- Do nothing: Do not consolidate English food hygiene and food safety legislation

7
This defence is available where the person charged proves that they ‘took all reasonable precautions and exercised all due diligence to avoid
the commission of the offence by himself or by a person under his control’.

6
17. Under Option 1, there would be no change. Any potential benefits resulting from the proposed
consolidation could not be taken up and the FSA would not meet its obligation to simplify the
structure of food safety/hygiene legislation under the Red Tape Challenge initiative.

Option 2 - Proceed with the consolidation of the legislation

18. Under option 2, all current national legislation on food hygiene and food safety in England would be
consolidated into one instrument. This would benefit both enforcement and food businesses, which
after the change would only have to refer to one instrument. Option 2 is therefore the preferred
option.
Other options considered
19. Consideration was given to replacing The General Food Regulations 2004 (as amended) and The
Food Hygiene (England) Regulations 2006 (as amended) with guidance. This option was rejected
as not being viable for the reasons explained in Appendix B.
Q4: Are there are other options that should be considered? If so please explain what these
options are and why they should be considered.

Sectors and Groups Affected

Industry
20. The consolidation will impact on food businesses in England, all of which must comply with national
legislation on food hygiene and food safety. According to LAEMS data8, there were 490,308 food
business operators in England in 2011/20129. LAEMS does not hold information on firm size, but
we have used IDBR 201210 to calculate the proportion of food related businesses that are micro,
small, medium and large. Table 1 below shows these proportions. Note that the IDBR dataset is for
the UK as a whole and it is not possible to get firm size for England only, at the level of detail we
require. The proportions in Table 1 below should therefore be treated with caution and as indicative
estimates. Percentages may not total 100 due to rounding.
Table 1: Food Businesses in England by Firm Size
Micro <10 Small <50 Medium <250 Large 250+ Total
438,376 46,423 4,468 1,041 490,308
% of Total 89.4% 9.4% 0.9% 0.2%

Enforcement Authorities
21. The consolidation will impact on professional local authority enforcement officers that enforce food
law. According to LAEMS there were 1,422 officers occupying posts enforcing food hygiene and 576
officers occupying posts enforcing food standards. A total of 1,998 enforcement officers.
Consumers
22. We do not envisage that the consolidation would have any impact on consumers as it is our
assumption that the regulations are mainly used by enforcement authorities and businesses.
Q5: Do stakeholders consider that there are sectors other than food businesses and enforcers
that would be affected by the proposed consolidation? If so please explain who these are and
how they will be affected.

Option Appraisal

Option 1- Do nothing - Do not consolidate English food hygiene and food safety legislation

8
LAEMS (Local Authority Enforcement Monitoring): http://www.food.gov.uk/enforcement/monitoring/laems/
9
www.food.gov.uk/multimedia/pdfs/board/fsa121106.pdf
10
IDBR 2012, Table B3.1, http://www.ons.gov.uk/ons/rel/bus-register/uk-business/2012/rft-uk-business-2012.xls
7
Costs and Benefits

23. There are no costs or benefits associated with this option. This is the baseline against which all
other options are appraised.

8
Option 2 - Proceed with the consolidation of The General Food Hygiene Regulations 2004 (as
amended) and The Food Hygiene (England) Regulations 2006 (as amended).

Costs to Industry

Familiarisation Costs

24. In itself, the consolidation of national food legislation into one statutory instrument would not change
any of the requirements on business contained in the legislation; it is therefore our assumption that
any associated familiarisation costs would be negligible.
Q6: Do business stakeholders agree that any additional cost from the consolidation will be
negligible? If not please explain what the impact would be and an estimate of the additional time
and cost, either in total, or for your businesses.

Costs to Enforcement

Familiarisation Costs

25. The consolidation of national legislation into one statutory instrument would not change any
requirements contained in the legislation. It is therefore our assumption that any familiarisation costs
associated with the fact that two statutory instruments are now located in one document would be
negligible.
Q7: Do enforcement stakeholders agree that any familiarisation costs from the consolidation will
be negligible? If not please explain what the impact is and give and an estimate of any additional
time and cost.

Costs to Consumers

26. We do not envisage that the consolidation will result in any costs to consumers.
Q8: Do stakeholders agree with the FSA’s assessment that the consolidation will impose no
costs on consumers? If not please where possible provide data to support your view.

Benefits to Industry

Reduced familiarisation time for new entrants into the sector (on-going)

27. There may be simplification benefits to industry as a result of the consolidation of national food
legislation. Any new entrant business into the sector would only need familiarisation with one single
principal statutory instrument instead of two and a number of amending instruments. It is difficult to
estimate how many new businesses will enter the sector over the next ten years. We have,
however, looked at historical data on entrants into the sector, which shows that, over the past two
years, the average number of new businesses entering the sector was around 6,700 per annum (we
only have data for two years). While we know that this figure is not necessarily representative for the
future, if we assume that it is, we can calculate an indicative estimate of a potential simplification
benefit to industry.
28. To calculate an indicative estimate of this benefit, we assume that it currently takes one manager
per business two hours to read and familiarise themself with the current legislation and that after the
consolidation, familiarisation would only require one hour. We can then monetise this benefit as a
time saving, multiplying the time saved per officer (1) by the wage rate of the business manager

9
 (£26.1011) and then again by the number of new entrants into the sector per annum (6,700). This
would then generate a total time saving per annum to industry of £174,870.
Q9: Do businesses agree that the FSA’s estimation of one hour for a manager to read and
familiarise themselves with the proposed consolidated SI? If not please where possible provide
data to support your view.

Benefits to Enforcement

Reduced familiarisation time for new entrants into the sector

29. There may be simplification benefits to enforcement officers as a result of the consolidation of
national food legislation. Any local authority officer taking up employment in the sector would have
to familiarise themself with just a single principal statutory instrument instead of two and a number of
amending instruments. It is difficult to estimate how many new officers will enter the sector over the
next ten years but analysis of data on new entrants for the past two years shows that the total
number of officers has decreased (we do not have any data dating further back). If we assume this
is representative of the sector in the future, no simplification benefits would be realised. Due to lack
of data and future uncertainty we have therefore not monetised this potential benefit.
Q10: Do enforcement stakeholders agree with the FSA’s estimation that new entrant enforcers
will take less time to familiarise themselves with the proposed consolidated SI than the current
two separate SIs? If not please where possible provide data to support your view.

Benefits to Consumers

30. We do not envisage that the consolidation will result in any substantial benefits to consumers.
Q11: Do stakeholders agree with that FSA’s estimate that the consolidation will not result in
benefits to consumers? If not, please where possible provide data to support your view.

Summary of total benefits under Option 2

31. We envisage that the consolidation of the national food legislation into one statutory instrument will
generate benefits to businesses and enforcement in terms of a time saving to future entrants into the
sector, which from the time of its coming-into-force, will only need to refer to one document. It is
difficult to estimate how many businesses and enforcement officers will enter the sector in the
nearest few years and we have limited historical data. We have, however, calculated an indicative
estimate of an annual time saving to industry of £174,870 (£1.5m, present value).

Table 2: Summary of Total Benefits under Option 2 (£)

Summary of total costs and benefits under Option 2

32. We do not envisage any substantial costs to businesses, enforcement or consumers under Option 2.
It is therefore our assumption that the consolidation would have a net beneficial impact. It is difficult
to monetise these benefits since the future is uncertain, but we have calculated an indicative
estimate of around £1.5m (see previous paragraph).

11
Wage rate obtained from The Annual Survey of Household Earnings (2011) (http://www.ons.gov.uk/ons/guide-
method/surveys/list-of-surveys/search/index.html?survey=Annual+Survey+of+Hours+and+Earnings+%28ASHE%29&content-
type=Dataset&content-type=Reference+table&sortDirection=DESCENDING&sortBy=pubdate). Median hourly wage of a
production manager (£20.08 which has been uprated by 30% to cover overheads: £20.08 * 1.3 = £26.10
10
Q12: Do stakeholders agree with the rationale adopted by the FSA, that the risks and
assumptions are reasonable and that the costs and benefits are a reasonable assessment of the
impact of this Option?

Statutory Review
33. The FSA is required by the UK Government to carry out, where reasonable, a review every five
years on the way in which EU legislation for which the FSA has enforcement oversight is
implemented and enforced in other Member States. This review period begins when the proposed
Regulations that are the subject of this Impact Assessment come into force. In carrying out the
review, the FSA is required to produce a report that will assess whether the Regulations achieved
their intended objectives. The report will also assess if these objectives could be achieved by
means that impose less Regulation.

SPECIFIC IMPACT TESTS

Note: the Health and Wellbeing specific impact test is not in the list, because the whole of an FSA IA
focuses on food safety in the health context. If you wish to consider wider health issues, Department of
Health guidance is at http://www.dh.gov.uk/en/Publicationsandstatistics/Legislation/Healthassessment/DH_647

Type of test and link to guidance Click on a box for EACH row to
(Double click on each of the headings to follow link) show if the test is relevant or
not:
Relevant Not relevant

Competition assessment

Small firms impact test

Sustainability:

Economic impact

Social impact

Environmental impact

Carbon impact

Equality impact

Justice impact

Rural proofing

Human rights

Privacy impact

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Creation of new criminal offence

Impact on powers of entry

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Wider impacts

Competition assessment
34. As there are no changes to the requirements on businesses we do not believe there will be any
impact on competition from the proposed consolidation.

Small Firms Impact Test

35. The legislation being consolidated enforces EU Regulations that place requirements on (in different
ways depending on the sector) all food businesses in England. The majority of these businesses are
micro or small (see Table 1) and the IA considers the impact on these businesses. We do not
believe there will be any net cost or benefit to small businesses resulting from the consolidation.

Q13: Do stakeholders agree that there will be no net benefit or cost to small food business
operators as a result of the consolidation? If you disagree, please provide evidence to support
your views.

Sustainability
36. Impacts under the three pillars of sustainable development (environmental, economic and social)
have been considered in the preparation of this Impact Assessment. We do not consider that this
consolidation will have any impact on any of the three pillars.

Powers of entry
37. The Powers of Entry contained in national legislation for which the FSA has policy responsibility are
currently being reviewed and consulted on. Further details can be found on the FSA website1.
38. The General Food Regulations 2004 regulation 7 references section 32 of the Food Safety Act
which provides entry powers to food business establishments to ensure that unsafe food is not
placed on the market for public consumption.
39. The Food Hygiene (England) Regulations 2006 regulation 14 provides three powers of entry
• Power of an authorised officer of a food authority to enforce legislation that establishes the
conditions under which food is produced to prevent, eliminate or acceptably control pathogen
contamination of food.

• Power of an FSA official to enforce legislation that establishes the conditions under which food is
produced to prevent, eliminate or acceptably control pathogen contamination of food. Includes
risk based and flexible procedure matched to the needs of individual businesses and
enforcement.

• Power for an FSA official or authorised officer of a food authority to obtain a warrant from a JP to
enforce legislation that establishes the conditions under which food is produced to prevent,
eliminate or acceptably control pathogen contamination of food.

Q14: Do you agree with the retention of the above Powers of Entry? If not why not? Please
provide information and evidence in support of your argument.

Criminal offences
40. The number of offences has been reduced, in that the offence in the General Food Regulations
2004 of breaching certain Articles of Regulation (EC)178/2002 is no longer there; breach of those

1
http://www.food.gov.uk/news-updates/consultations/consultations-england/2013/fsa-review-poe

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 Articles is now subsumed into the breach of EU requirements that is made an offence under
regulation 19 of the draft consolidated SI.

APPENDIX A
EU food law – brief description
The principles and requirements of EU general food safety law are set out in Regulation (EC)
178/2002 and the requirements of microbiological food safety in the EU food hygiene
regulations2.
Regulation (EC) 178/2002 establishes and requires that:
- ‘unsafe’3 food must not be placed on the market;
- suitable and accurate information must be provided to consumers;
- there must be traceability of food; in that food businesses must be able to identify any
supplier or consignee; and
- food businesses must both inform the competent authorities and immediately withdraw
food from the market if they have a reason to believe that their food is not safe.

The EU food hygiene regulations place requirements on food businesses to produce and handle
food safely. They also place requirements on competent authorities4. The regulations include
the following requirements:
- registration or approval with the competent authority depending on the food business
establishment’s activities;
- food safety procedures based on HACCP principles5;
- food safety rules on foodstuffs, premises, equipment, transport and food handler hygiene
and training throughout the food chain, starting with primary production (e.g. fishing and
farming);
- application of basic common hygiene requirements, with specific rules for the
manufacture of products of animal origin and
- details of competent authority responsibilities in certain areas.

2
The basic EU food hygiene regulations are Regulation (EC) 852/2004 which lays down general food hygiene rules for all food businesses;
Regulation (EC) 853/2004 which lays down specific hygiene rules for products of animal origin; Regulation (EC) 854/2004 which lays down rules
for competent authorities; Regulation (EC) 2073/2005 which lays down microbiological criteria for foodstuffs and Regulation (EC) 2075/2005
laying down specific rules on official controls for Trichinella in meat. There are a number of other Regulations which amend, implement or
provide derogations from these Regulations and some standalone Regulations. These are listed on the FSA web site at:
http://www.food.gov.uk/enforcement/regulation/europeleg/foodhygimptrans
3
The definition of ‘unsafe’ is set out at Article 14 and means both ‘injurious to health’ and ‘unfit for human consumption’.
4
The ‘competent authority’ in the UK will be the local authority in all cases except establishments where the FSA has a veterinary presence, or
where the FSA has a central role to play such as general oversight of enforcement, dissemination of information or liaison with the European
Commission..
5
HACCP-based principles are not required for farming activities but procedures giving consideration to food safety hazards in farming are still
required.

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 APPENDIX B
Rejected Option - Replacing food hygiene and food safety legislation with guidance

Consideration was given to replacing The General Food Regulation 2004 (as amended) and
The Food Hygiene (England) Regulations 2006 (as amended) with guidance. This option was
rejected for the reasons explained below.

Both European treaty obligations and the EU Regulations themselves require the UK to ensure
that directly applicable EU regulations covering food safety and food hygiene can be enforced in
all parts of the UK. Guidance would not have any legal authority to enable enforcement action to
be taken against non-compliant businesses. This could result in the following:

• it could be detrimental to public health by allowing the sale of unsafe food and/or the
provision of misleading information about food being supplied. This could impact
disproportionately against vulnerable groups such as the elderly or persons with long-term
health problems with considerable loss of face for the FSA in England;
• it could have an adverse impact on food businesses that are compliant as they would be at a
disadvantage against those which were not as well as damaging the market for compliant
businesses by reducing consumer confidence in the food sector.
• it would probably result in UK food businesses being prevented from selling products to food
businesses located in EU Member States as free trade within the Community is predicated
on the application of common mandatory rules and their enforcement; and,
• it could result in infraction proceedings being brought against the UK by the European
Commission with the potential for considerable (although unknown) costs.

The familiarisation with new guidance would be disproportionate. We estimate that a one-off
cost to industry from reading and familiarisation with new guidance could be in excess of
£12million. This is based on the assumption that it would take one business manager per
business one hour to familiarise themself with the new guidance and then disseminate this
information to key members of staff. Assuming the median hourly wage rate of a business
manager is £26.10. Multiplying the wage rate (£26.10) with the number of hours required (1)
and the total number of business in the sector (490,308) results in a total familiarisation cost to
the industry of £12,797,038.

The familiarisation cost to local authorities is estimated to be around £40,000. This is based on
one enforcement officer taking one hour to familiarise themself with the new guidance. The
median hourly wage rate of an Environmental Health Officer is £20.466. Multiplying the wage
rate (£20.46) with the number of hours required (1) and the total number of enforcement officers
in the sector (1,998) results in a total familiarisation cost to the industry of £40,879.

6
Wage cost from the Annual Survey of Household Earnings (2011) (http://www.ons.gov.uk/ons/guide-method/surveys/list-of-
surveys/search/index.html?survey=Annual+Survey+of+Hours+and+Earnings+%28ASHE%29&content-type=Dataset&content-
type=Reference+table&sortDirection=DESCENDING&sortBy=pubdate3). Median hourly wage of an ‘Environmental health
officer’ is used and is £15.74, plus 30% overheads totalling £20.46.

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