For granting approvals for parallel trade, criteria are necessary to make comprehensible and consistent decisions. The criteria which are used by the Federal Office of Consumer Protection and Food Safety (BVL) as a basis for making decisions on applications according to Article 52 of Regulation (EC) No. 1107/2009 are listed below. Since this Regulation does not contain any defined criteria, such criteria were compiled by the European Commission and the Member States and put together in a guidance document. In principle, the guidance document, which can be retrieved on the right, is implemented in Germany with the exception of three items which cannot be implemented due to legal stipulations. These items are listed in the statement for the minutes which can also be retrieved on the right. For the criteria listed in the following, the stipulations according to Article 5 (3) of the Plant Protection Products Regulation were still taken into account.

The plant protection product which is intended for parallel trade can be considered for approval if all the following requirements are fulfilled:

1. The product intended for parallel trade is authorised in a Member State of the European Union

This criterion derives from Article 52 (1) of Regulation (EC) No 1107/2009

2. The plant protection product has a common origin

This criterion derives from Article 52 (3) (a) of Regulation (EC) No. 1107/2009. Plant protection products are considered as having a common origin if one of the following conditions applies:

• the authorisation holder of the reference product is the same as the authorisation holder of the plant protection product intended for parallel import or belongs to the same group of companies, or
• the authorisation holder in the Member State of origin is an affiliated company of the authorisation holder or vice versa, or
• the manufacturer to be named for the authorisation procedure for the plant protection product is the same for both plant protection products, or
• the products are manufactured within the scope of a license procedure - the license must originate from the authorisation holder or an affiliated company.

3. Identical content of active substances, safeners and synergists

This criterion derives from Article 52 (3) (b) of Regulation (EC) No. 1107/2009. Deviations in the declared active substance contents are generally not admissible. Differences due to varying declaration modalities in the Member States are accepted however. The same applies to safeners and synergists, where provisions exist at Community level for safeners and synergists.

4. The specifications of the active substances, safeners and synergists are identical

This criterion derives from Article 52 (3) (b) of Regulation (EC) No. 1107/2009. It is assumed that all Member States of the EU have evaluated the plant protection products according to current stipulations and in particular have implemented the stipulations for the approval of active substances and observed the reference specification which has been set. The result is the following approach to evaluation: if all the active substances in the plant protection product which is being applied for have been approved, and an EU reference specification for the impurities has been determined during the active substance approval, or according to Guidance Document SANCO/6075/2009, it is presumed that the specification is identical. If an EU reference specification has not been determined or an active substance has not been approved, the common origin of the active substance is checked first of all. If this can be confirmed, an identical specification for the active substances is presumed. If the active substance has no common origin, the maximum contents of the specified impurities are compared. According to the wording of Article 52 (3) b of Regulation (EC) No. 1107/2009, compliance with the maximum contents of the reference source is decisive. The same applies to safeners and synergists, where provisions exist at Community level for safeners and synergists.

5. The types of formulation are identical

This criterion derives from Article 52 (3) (b) of Regulation (EC) No. 1107/2009. The BVL does not only evaluate the identity of the type of formulation according to the declaration in the authorisation, but where necessary based on the type of formulation used for the reference product and for products approved for parallel trade. An overview of the most important types of formulations can be found on the BVL website under "Plant Protection Products > Product Chemistry"

6. The plant protection product co-formulants are identical or comparable

This criterion derives from Article 52 (3) (c) of Regulation (EC) No. 1107/2009. According to the Regulation, co-formulant deviations which could potentially lead to disadvantageous effects on the safety of the product concerning human and animal health and the environment are not acceptable. To consolidate this requirement, the guidance document stated above and the Plant Protection Products Regulation provide for exclusion criteria. According to these criteria, co-formulants are not considered identical or comparable if:

• the product intended for parallel trade contains a co-formulant or a co-formulant substance which has not been authorised in any plant protection product in Germany
• co-formulants or co-formulant substances which have a significant function are missing
• the product intended for parallel trade contains other dispersing, emulsifying or wetting agents

• co-formulants which have a significant function deviate in their nominal content from the reference product to a greater extent than stated in the following table
  

Nominal content in g/kg or g/L a 20 °C ± 2 °C	Maximum permissible deviation from nominal content
up to 25	± 15% for homogeneous formulations (EC, SC, SL, etc.) ± 25% for heterogeneous formulations (GR, WG, etc.)
more than 25 up to 100	± 10%
more than 100 up to 250	± 6%
more than 250 up to 500	± 5%
more than 500	± 25 g/kg or g/L

• There are co-formulant substances which are more toxic or ecotoxic than those contained in the reference product.
• There are co-formulant substances which are less favourable for efficacy or stability than those contained in the reference product.
• Co-formulants intended for operator protection are missing, in particular repellents, water soluble bags or colouring agents if these have a significant protective function for the operator.
• Co-formulants intended for the protection of third parties are missing.
• The sum of all deviations is more than 10% in relation to the reference product.

7. Size, material and shape of the packaging must be identical or comparable

This criterion derives from Article 52 (3) (c) of Regulation (EC) No. 1107/2009.

The responsible authorities of the Member States are obliged to check whether the size, material and shape of the packaging is identical or comparable with regard to the safety of the product for humans, animals and the environment. Regulation (EC) No. 1107/2009 assumes that plant protection products will be imported in the original packaging from the Member State of origin. However, it may be necessary to repackage goods to ensure their free movement. This must be done by a suitable and professional establishment in order to avoid loss of quality.

If the product is imported in the original packaging, the BVL checks to see whether the packaging is comparable with the packaging of the German reference product, if this was defined by the authorisation for the reference product, by using the data submitted by the Member State of origin. If the product is repackaged, the intended packaging is checked by using the data from the applicant to see whether it is comparable.

As far as the packaging size is concerned, the BVL differentiates between four categories which are oriented around product safety requirements, including handling:

• under 1 L (or kg)
• over 1 L up to 20 L (or kg)
• over 20 L up to 1000 L (or kg)
• over 1000 L (or kg)

The packaging size is considered comparable if it belongs to the same category as the reference product or smaller. If the packaging belongs to a larger category, it is examined individually. The authorised packaging for the reference product always applies to packaging for non-professional users. In individual cases, packaging which deviates from this may be approved.

At all events, the storage stability of the product intended for parallel trade must be tested with the intended packaging material. If this should not be the case, the comparability of packaging material and shape are examined individually.

If the packaging is not comparable with regard to the safety of the product for humans, animals and the environment, the BVL informs the applicant, stating admissible container sizes, shapes and materials in the approval. In this case the applicant is obliged to have the product repackaged by a suitable establishment.