Products that are explosive (E) or oxidizing (O) must not be authorised for use by non-professional users.

Acute Inhalation Toxicity:

Until a change in condition i) of the data requirement for inhalation toxicity of Regulation (EU) No 284/2013 has been made, or a harmonised EU interpretation of this condition has been established, an acute inhalation toxicity study should be required according to the old data requirement on testing for inhalation toxicity (Regulation (EU) No 545/2011).

Non-professional use: (reference document available in Norwegian)

The directions for authorisation of non -professional use:

Important issues are:

-use of substitutional principle

• evaluation regarding storage of the plant protection product
• evaluation regarding personal protection equipment for non-professional users lacking skills in handling plant protection products.
  

The following plant protection products may not be authorised for use by non-professional users:

Products that are acutely toxic category 1-2 (deadly) or category 3 (toxic); that are corrosive for the skin and eyes or can cause serious eye damage; that may cause allergy or asthma symptoms or breathing difficulties if inhaled;

that may or possibly may give cancer, genotoxic effects or impair fertility or the unborn childs (CMR-substances) or that cause or may cause damage to organs by single or repeated exposure.

Thus, plant protection products in Norway for non —professional use labelled with one or more of the following risk phrases according to CLP, will not be authorised:

• H300 Fatal if swallowed.
• H301 Toxic if swallowed.
• H304 May be fatal if swallowed and enters airways
• H310 Fatal if in contact with skin.
• H311 Toxic if in contact with skin.
• H314 Causes severe skin burns and eye damage.
• H318 Causes serious eye damage.
• H330 Fatal if inhaled.
• H331 Toxic if inhaled.
• H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• H335 May cause respiratory irritation
• H336 May cause drowsiness or dizziness
• H340 May cause genetic defects.
• H341 Suspected of causing genetic defects.
• H350 May cause cancer
• H351 Suspected of causing cancer.
• H360 May damage fertility or the unborn child.
• H361 Suspected of damaging fertility or the unborn child.
• H362 May cause harm to breast-fed children
• H370 Causes damage to organs.
• H371 May cause damage to organs.
• H372 Cause damage to organs through prolonged or repeated exposure.
• H373 May cause damage to organs through prolonged or repeated exposure. For products containing substances carcinogenic, reprotoxic or toxic by prolonged exposure below the classification limit, estimating exposure without personal equipment will be done. If the exposure is above the AOEL, the product will not be approved for non-professional use.
  

The following PPPs can be accepted for non-professional use:

* Ready for use: Plant protection products without classification/labelling, or with irritating characteristics (if there are no better alternatives). These products will not be approved if there is extensive need for personal protection equipment.

* Concentrate: Plant protection products with irritating characteristics may be approved. Products labelled as harmful to health may be approved if there are no better alternatives (health). These products will not be approved if there is extensive need for personal protection equipment

Powder soluble in water: Powder soluble in water is not suitable for non-professional use because of the danger for exposure. But if the products are delivered in small disposable packages as water soluble bags they may be accepted for non-professional use

worker assessment: Worker assessment for non-professional users will be considered case by case. As an example, ornamentals indoors and use of plant rodlet (via soil insertion) would not be considered relevant.

The Norwegian Food Safety Authority is the responsible authority.

Obviously, the dossier must cover norwegian conditions.

The Norwegian Institute of Bioeconomy Research is responsible for the efficacy evaluations.

Directions for approval of non-professional use:

When evaluating such products persistence is especially important. Products that have a mean half-life in soil of more than 100 days will not be authorised for outdoor use.

Directions for labelling of PPPs toxic to bees:

A pictogram of a bee may be required on the label*. The bee pictogram shall be applied if an evaluation according to the uniform principles shows for one or more of the labelled uses that risk mitigation measures must be applied to protect bees or other pollinating insects.

While waiting for the update of the EFSA Bee guidance document, the bee pictogram shall also be applied if risk mitigation measures need to be applied to protect bees or other pollinating insects according to the interim methodology in the Northern Zone.

Furthermore, the plant protection product shall be labelled with the bee pictogram if the acute oral or contact LD50 for the product (given as µg a.s./bee), active substance or relevant metabolites is lower than or equal to 11 μg/bee.

The bee pictogram shall always be accompanied by the phrase «SPe 8 Dangerous to bees».

The bee pictogram will be attached to the decision letter.

Permanent greenhouses

Directions for labelling of PPPs authorised for use in permanent greenhouses: Greenhouse products may, depending on their environmental profile, be identified as a “spesialpreparat for veksthus” *

*Criteria for defining a ppp as “spesialpreparat for veksthus” are under development.

Non-professional uses

Directions for authorisation of non-professional use:

As a general rule, products that are in focus because of their ecotoxicological profile, should not be authorised for non-professional use. When evaluating such products, toxicity to bees is especially important. Products that are very toxic too bees/pollinating insects (LD50 <1.0 a.s. μg/bee) will not be authorised for outdoor use

National requirements for approval of adjuvants

(see here ).

The Norwegian Food Safety Authority will perform the assessment for the product, containing a candidate for substitution . The steps of the CA will be included it in the final Part A of the Registration Report. The applicant will be given the possibility to comment, if the conclusion of the CA is negative for the applicant.

Mandatory Comparative Assessment - Article 50.1

The applicant should submit the information to support the process of comparative assessment, by using the template in the Appendix of SANCO/11507/2013.

Optional Comparative Assessment - Article 50.2

The Member State may in exceptional cases also perform an optional CA when evaluating an application for authorisation of a plant protection product not containing a candidate for substitution or a low-risk active substance, if a non-chemical control or prevention method exists for the same use and it is in general use in that Member State.

The applicant should address the following question in the application for the plant protection product

Does a non-chemical control or prevention method exist for the same use and is it in general use in the Member State?

This information could be included in the Part A of the Registration Report, chapter 4