4.3 Determining the scope of the Feed Safety Management System

• § 1.5, § 4.1, B1
• § 1.5, § 4.3, B2
• § 1.5, § 4.3, B3
• § 1.5, § 4.3, B4
• § 3.2 , A1

• Feed materials which are delivered to livestock farmers are not necessarily ensured anymore by the GMP+ certificate. This depends on “the needs of the relevant interested parties” (livestock farmers)

4.4 Feed Safety Management System

• § 4.1, B1
• § 4.3, B2/B3/B4

• Related to FSMS, in entire R 1.0 document the term ‘documented information’ is used instead of ‘documents’, ‘registrations’, ‘documented procedures’ and ‘manuals’

5.1 Commitment of the top management

• § 5.1, B1
• § 4.1, B2/B3/B4

• f), g) and h) are new in the list of responsibilities of the (top) management of a GMP+ certified company

5.2 Feed safety policy

• § 5.2, B1
• § 4.4.1, B2
• § 4.1, B3/B4

• There is more emphasis on the communication of the feed safety policy in the company

5.3 Responsibilities

• § 5.4.1, 5.4.2, 5.4.3, § 7.9, B1
• § 4.1, § 4.2, § 5.1.1, § 6.8.1, B2
• § 4.1, § 4.2, § 5.1.1, § 6.2, B3
• § 4.1, § 4.2, § 5.1.1, § 6, B4

• Each GMP+ certified company must have a validation team. This was not included in B4
• Included is that all persons at the GMP+ certified company have the responsibility to report potential and actual problem(s) with regards to the FSMS to assigned person(s)/roles

6.1 FSMS Objectives

• § 5.3, B1
• § 4.3, B2
• § 4.1, 4.3, B3
• § 4.1, B4

• The certified company must act on objectives in a more planned way

6.2 Changes on the FSMS

• § 5.3,2, B1

• Implementing changes must be done in a more planned way. This is new compared to the standards B2, B3 and B4

7.2 Competences

• § 5.4.1, 5.4.2, § 6.2, B1
• § 4.2, § 5.1, B2
• § 5.1, § 6.2, B3
• § 5.1, B4

• There needs to be a description of the organisation related to FSMS
• It is no longer needed to make an organisational chart

7.3 Awareness

• § 6.2, B1
• § 4.1, § 5.1, B2/B3/B4

• Individuals, either internal or external, working under the control of the certified company must be aware of the feed safety policy of the company and the individual contribution to effectiveness to the feed safety of the FSMS and the feed
• c) and d) are new compared to the standards B2, B3 and B4

7.4 Communication

• § 5.4.5, § 7.2,4 B1
• § 6.2, § 7.1.2, § 8.1, B2
• § 6.3, § 7.1.2, § 8.1, B3
• § 7.2.1, § 8.1, B4

• The certified company must determine what it will communicate, when to communicate, who it will communicate to, how to communicate and who communicates

7.5 Documented information

• § 4.2, B1
• § 4.4, B2/B3/B4

• The requirement to have procedures is replaced by the requirement to have documented information. Note: for EWS and Recall a procedure is still required.
• The requirement on the minimum frequency (at least annually) of documentation assessment is removed
• The focus is more on the goal requirement to keep documents up-to-date and to revise in case of changes

8.4 Incident management

• Not applicable

• This topic is new. It has been taken over from ISO 22000

8.7 Control of non-conform products and processes

• § 6.6, § 7.8, B1
• § 5.5, § 6.7, § 7.4.2, B2
• § 5.5, § 6.8, § 7.2.7, § 7.1.5, B3
• § 5.5, B4

• The specifications of corrections and corrective actions are streamlined with ISO22000
• The time frame within which customers must be informed about exceeding limits, is now risk based (was: within 12 hours)

9.1 Monitoring, Measurement, Analysis and Assessment

• § 8.1, § 8.3, B1
• § 8.3, B3
• § 8.3, B4

• There is more focus on analysing and evaluating data that come from monitoring and measurement

10.1 Nonconformity and corrective actions

• § 8.4.2, 8.4.3, B1
• § 6.7, B2
• § 6.8 , B3

• There is more focus on evaluating the non-conformities, causes and corrective actions

TS1.1 Prerequisite programme

2. Maintenance

• §6.3.2.3, §6.4.1, B1
• §5.3.1, §5.3.2, B2/B3
• §5.3.1, B4

• Calibration of equipment for weighing/dosage of premixtures, feed additives and veterinary medicinal products is changed from ‘at least twice a year’ to ‘at least once every six months’

3. Personal hygiene

• §6.2.1, B1
• §5.1.1, B2/B3/B4

• The requirement to establish and implement rules with respect to eating, drinking and smoking is now for all companies risk-based
• It is not required anymore to have separate facilities for eating, drinking and smoking. Instead these are only allowed in designated areas

4.2 Water and steam

• §6.3.2.4, B1
• §5.2.4.3, B2
• §5.2.4, B3
• §7.3.2, B4

• The requirement has been added that water supply installations must be manufactured from inert materials

5. Pest control

• §6.4.3, B1
• §5.3.4, B2/B3
• §5.3.2, B4

• Waste management is mentioned as preventive manner to pest control
• The requirement that employees carrying out pest control operations must comply with legal provisions is new compared to the standards B1 and B2

8. Prevention of cross-contamination

• §6.7.1.5, B1
• §5.5, BA2

• Text is improved in order to clarify the difference between prevention of cross-contamination in general and the prevention of specific cross-contamination as a result of use of critical feed additives and/or veterinary medicinal products
• A carry-over test is no longer mandatory

TS1.4 Forbidden Products and Fuels

1. Products not allowed to be used in feed

• §4.1, §4.2, §4.3, BA3

• Sources of legislation are removed. This information is available in a guidance
• S9.5 Legislation and relation to GMP+ FC

2. Forbidden fuels for direct drying

• §5, BA3

• Source of legislation is removed. This information is available in a guidance S9.5 Legislation and relation to GMP+ FC

TS1.7 Monitoring

1.1 Monitoring plan

• §1.3, §2.1, BA4

• In case of overlap between different monitoring requirements, the GMP+ certified company must apply the strictest monitoring requirements
• ‘Chance’ changed into ‘likelihood of occurrence’
• ‘Seriousness’ changed into ‘severity’
• ‘Test’ changed into ‘monitoring’
• A general requirement is added that sampling must be done in accordance with the requirements as laid down in TS1.6 Sampling

1.2 Monitoring frequency

• §2.1, BA4

1.3 Sampling

• §2.2.5.1, §2.4.5, BA4

1.4 Collective monitoring plan

• §2.1 Note j, BA4

4. Monitoring protocol of Animal Protein

• §4, BA4

• Removed to avoid duplications with R1.0 Feed Safety Management Systems Requirements: ‘Additional corrective actions in the event of the norm being exceeded’

5. Monitoring protocol of oils and fats as regards dioxin and dioxin like PCB’s

• §2.2, BA4

• Removed from definition table within document to F0.2 Definition list:

1. ‘Products derived from oils and fat’
2. ‘Refined oil or fat ’
3. ‘Representative sampling

6 Monitoring protocol for by-products of the oils and fats industry

• §2.3, §3.1, BA7

• ‘9.5.1. Analyse method’ is new

TS1.8 Labelling

1. Labelling

• §2.1, BA6
• §3.1, BA7

• Removed: ‘The applicable legal requirements when selling products for non-food, non-feed applications are to be met as well’

2. Positive declaration

• §2.2 BA6

• The positive declaration may now be written in (at least one of) the official languages of the country where the feed is marketed or a language understood by the customer without:

- the approval of GMP+ Int. and

- the inclusion of the translation in the list with approved GMP+ declarations.

Appendices 1-2

• Annex 1, BA6
• Annex 2, BA7

• Appendix 2 is new

TS1.9 Transport activities

1. Introduction

• §1.1 - §1.5, B4

• A guidance for the reader is added

4.2 Transporting of feed

• §7.3.1, §7.3.2, §5.2.2, B4

• Requirements on combination vehicle are more detailed

TS1.10 Operational activities

1.2 Processing aids

• §6.3.2.4, B1
• §5.2.4.4, B2
• §5.2.4 B3

• The requirement to only use legally-permitted processing aids is taken out

1.7 Cleaning, sieving, filtering

• §7.2.4, B3

• ‘Checked’ changed to ‘verification and validation’

1.8 Returns

• §6.7.1.6, B1
• §7.4.2, B2
• §7.1.5, §7.2.4, B3

• Removed: ‘internal returns are limited as far as possible’
• Removed: ‘Return flows of premixtures may only be added to premixtures destined for target animals’
  - ‘Rework activities involve removing a product from filled or wrapped packages’ is new.

1.9 Storage

• §6.3.2.2, B1
• §7.3.1, B2
• §7.2.3, §7.2.6, §7.2.8, B3

• The requirement to ‘keep temperatures as low as possible and show as little variation as possible to prevent condensation and decay’ is transferred into a helpful tip.

TS1.11 Control of residues & homogeneity of critical feed additives and veterinary medicinal products

3.1 General / installation

• §4.1, BA2
• §4.2.1, BA2

• New suggested control measure (disposal/rework) is added in the helpful tip
• The company is no longer obligated to measure the carry-over of the production installation.
• The carry-over measurement can be used to establish a calculated production sequence based on the percentage of carry-over.

4.2 General basic principles with respect to the measurement of carry-over

• §5.2, BA2

• Removed: the paragraph ‘Possible measurement substances’
• The Cobalt method is not mentioned anymore as the reference method for new measurement substances
• Removed: the Cobalt method for measuring carry-over

4.3 Testing procedure for the carry-over in compound feed mixing using a mix of manganese oxide and a protein-rich and a protein-poor mix

• §5.5, BA2

• ‘RE’ changed into ‘CP’

4.4 Testing procedure for the measurement of carry-over in premix and additives installations

• §5.6, BA2

• Cobalt mixes are taken out from 3. Tracer substance to be used

4.5 Checking procedure for the process accuracy of compound feed with micro tracers

• §5.7, BA2

• Removed: the method for measurement of carry-over using micro-tracers (§5.8, BA2)
• Removed: the method for measurement of carry-over in animal feed preparation using methyl violet (5.9, BA2)