FAQ Pesticide residues (GMP+ D.xx) (DRAFT)

20 października 2016

Relating to HACCP, a participant must determine - for each Critical Control Point (CCP) - the measuring values in which the safety of the product can be guaranteed. For this pur-pose, specific feed safety limits for undesirable substances have been established in the GMP+ Feed Certification scheme (GMP+ FC scheme). These limits are included in Appen-dix 1 of the GMP+ FC scheme: GMP+ BA1 Specific Feed Safety Limits. For pesticides, the limits are based on EU legislation*:

  • Directive (EC) No. 2002/32. In this directive, the forbidden/prohibited pesticides are included. This is included in part 3 of GMP+ BA1 and
  • in Regulation (EC) No. 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin. This is included in part 4 of GMP+ BA1.

The content of both legislations is integrated in the EU Pesticide database (EU PDB).

EU legislation is included in the GMP+ requirements. This means that it applies to all GMP+ participants all over the world.

It should also be taken into account that, when national legislation is stricter than the GMP+ BA1 requirements, the GMP+ participant must respect the requirements of that legislation. GMP+ International advises to communicate with your customers about possible stricter requirements from national legislation. This way, you can take into account the requirements which your product must meet and prevent problems further down the supply chain!

* For more information, please see our newsletter “Relationship between GMP+ FSA certification and EU legislation”

GMP+ International has received questions from its participants about the requirements in the GMP+ FC scheme regarding the applicable MRLs for pesticides in feed. Below, we have described and answered the most frequently asked questions.

Should you have any further questions or would like to receive more information, you can always contact us via our contact form.  If necessary, this list will be expanded.

Which standards/MRLs apply?

Feed materials can originate from any country across the globe and can have any country in the world as a destination. Companies have to be aware of this. There are different situations that need to be taken into account. In the table below, different situations will be explained including whether GMP+ BA1 Specific Feed Safety Limits applies. This is a non-exhaustive list.

No

Situation

GMP+ BA1 applicable?

Additional information

1

The product is purchased and traded as a non- GMP+ certified product

 

No

Non-GMP+ certified products are out of the scope of GMP+ certification

 

2a

The product is purchased as a non-GMP+ certified product and traded as GMP+ certified product

 

Yes

This can be the situation in case of GMP+ BA10 Minimum Requirements for Purchasing: Gatekeeper protocol for purchase of grains, seeds and legumes

See the situations below for more information.

2b

The product is purchased as a GMP+ certified product and traded as GMP+ certified product?

 

Yes

Only when national legislation is stricter than GMP+ BA1 regarding pesticides, the participant must observe these stricter requirements under legislation.

Communication with your customer may help you to obtain this information. This way, you can take into account the requirements your product must meet.

2c

There is a difference in country of origin of the product and country of destination of the product.

 

E.g.: Product is cultivated in South America (non EU) shipped to European country for further processing. Then traded outside EU as GMP+ certified product

 

 

Yes

Only when national legislation is stricter than GMP+ BA1 regarding pesticides, the participant must observe these stricter requirements under legislation. You have to consider that there can be a difference in MRL between the country of origin and the country of destination. The lowest MRL is applicable. Communication with your customer may help you to obtain this information. This way, you can take into account the requirements your product must meet further down the chain.

2d

Only the next link/destination is known

 

Yes

Communication with your customer may help you to obtain this information. This way, you can take into account the requirements your product must meet further down the chain.

How to determine a pesticide MRL in feed?

To help you determine what the applicable MRL in feed is, GMP+ International developed a decision tree. You can find this decision tree in Annex 1.

Is it allowed to use transfer factors (concentration factors)?

Yes, GMP+ International has adopted the MVO/FEDIOL approach/methodology.

This means the following:

  • Use the transfer factors in accordance with FEDIOL (where possible/applicable)
  • For other products than those mentioned in the “FEDIOL paper” an individual calculation must be made. Where required, it must be submitted for approval to the competent authority.
  • In the absence of a calculation or the inability to apply transfer factors, the MRL of the primary/basic/unprocessed product must also be used for the byproduct.

GMP+ International advises to communicate with your customers about the application of transfer factors.

For more information, consult the MVO website.

Which MRL is applicable on not approved/forbidden pesticides in feed products?

There are 2 options:

  1. the forbidden/prohibited pesticides are mentioned in part 3 of GMP+ BA1 Specific Feed Safety Limits;
  2. the MRL of the not approved pesticides can be found in EU database.

Both information (a and b) is available in the EU pesticide database.

If the pesticides are not mentioned in the EU database, the default value (default MRL) of 0.01 mg/kg applies.

Is any feed product exempt from an MRL?

Feed products exempt from an MRL are identified in table 2 of the current version of GMP+ BA1 Specific Feed Safety Limits.

In the current version of GMP+ BA1 Specific Feed Safety Limits, the changed European legislation (“footnote 1”*) related to the content of table 2 is not implemented. It is currently unclear how this changed European legislation has to be included in GMP+ BA1 Specific Feed Safety Limits. This topic will be discussed in a workgroup. As long as there is no clarity, the current GMP+ BA1 Specific Feed Safety Limits is in effect. Please note that when the national legislation is stricter than the limits in GMP+ BA1 Specific Feed Safety Limits, the participant must observe these stricter requirements under legislation.

* The so-called “footnote 1” is part of the new feed legislation. The text of footnote is:  ‘MRLs do not apply to products or parts of the product used exclusively as ingredients for animal feed’.

Can the measuring uncertainty be taken into account?

No. For the determination of a limit exceedance, you must assume the measured analysis result. You cannot deduct the measuring uncertainty. You cannot market products that exceed the maximum permitted limit.

How can I determine the pesticide-MRL for my feed product? Examples

A couple of examples of calculations for the MRL product/pesticide combinations have been prepared and presented via MVO website.

Clarification of European legislation regarding pesticides in feed and why GMP+ BA1 Specific Feed Safety Limits has not yet been updated

Regulation (EG) No. 396/2005 contains the maximum residue levels (MRL) for primary agriculture products of vegetable and animal origin intended for human consumption and for feed. The structure of the Regulation (EG) No. 396/2005 is as such that in many cases, it is not immediately possible to indicate a MRL for a certain combination of feed/pesticide.

Unfortunately, in some cases the EU legislation is unclear (or the information is not complete). At the same time the authorities in the EU may have different opinions/interpretations of the legislation. In such cases it should be noted that companies should consult the competent authorities.

Whether the use of transfer factors for pesticides is permitted in a (European) country depends on the interpretation of the competent authority in the country or region. Unfortunately, currently there is no harmonization at a European level.

Communication with your customer may help you to obtain this information. This way, you can take into account the requirements your product must meet.

In the current version of GMP+ BA1 Specific Feed Safety Limits, the changed European legislation (“footnote 1”*) related to the content of table 2 is not implemented. It is currently unclear how this changed European legislation has to be included in GMP+ BA1 Specific Feed Safety Limits. This topic will be discussed in a workgroup. As long as there is no clarity, the current GMP+ BA1 Specific Feed Safety Limits is in effect. Please note that when the national legislation is stricter than the limits in GMP+ BA1 Specific Feed Safety Limits, the participant must observe these stricter requirements under legislation.

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