Confidential treatment of information can be granted if the applicant submit a request according to article 63. This is done by filling in and submitting the form below:
Download the form by using this link
A request for confidential treatment of certain information can be submitted in the following cases:
- To an Application for authorisation or amendment of an authorisation (Art. 33).
- To a Renewal of authorisation (Art. 43).
- To a Mutual Recognition (Art. 40).
The Danish Environmental Protection Agency asks the applicant to submit the documents of the application with a light colored and transparent marking, so that the Danish Environmental Protection Agency is in no doubt about which information confidential treatment is requested. In this way, the applicant ensures that the Danish Environmental Protection Agency does not overlook information to which the request for confidential treatment refers to.
Information covered and verifiable justification
Confidential treatment can only be granted with regard to the following information if it is demonstrated by the applicant that disclosure of the information in question could potentially harm its interests to a significant extent:
- The manufacturing or production process, including the method and innovative aspects thereof, as well as other technical and industrial specifications inherent to that process or method, except for information which is relevant to the assessment of safety;
- commercial links between a producer or importer and the applicant or the authorisation holder, where applicable;
- commercial information revealing sourcing, market shares or business strategy of the applicant;
- quantitative composition of the subject matter of the request, except for information which is relevant to the assessment of safety;
- the specification of impurity of the active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant and the related methods of analysis for such impurities;
- results of production batches of the active substance including impurities; and
- information on the complete composition of a plant protection product.
The applicant lists which information is requested to be treated confidentiallyin the form. For each information listed in the form, the applicant must accompany the request with a verifiable justification and reference to the relevant provision in Article 63(2) a) – d).
Decision on confidential treatment of certain information
The Danish Environmental Protection Agency evaluates each request separately, after which either full or partial confidential treatment will be granted. The Danish Environmental Protection Agency can also refuse a request if the information is not covered by Article 63(2), or if the applicant has not sufficiently justified the request. It is the responsibility of the applicant to justify why an information is covered by Article 63(2) a) – d).
After the evaluation, the Danish Environmental Protection Agency will make a decision on the granting of confidential treatment.
The Danish Environmental Protection Agency takes the necessary measures to so that information for which confidential treatment has been granted is not made public.
What happens to information where confidential treatment has been granted?
If, upon request, the Danish Environmental Protection Agency decides to treat certain information confidential, the applicant will be informed of the decision. Here it will be stated which information the Danish Environmental Protection Agency has decided to treat as confidential.
This means that the Danish Environmental Protection Agency will not publish or pass on the information to third parties. In practice, the Danish Environmental Protection Agency will create a sanitized document in which the confidential information will not appear (crossed out or blacked out). This document is called the "sanitized version". In this way, the Danish Environmental Protection Agency can publish or pass on this cleaned document without breaking confidentiality.
It is therefore important that the applicant specifically refers to the information for which confidential treatment is requested, so that the Danish Environmental Protection Agency can cross out this information in the sanitized document. This means that it is necessary for the applicant to also indicate where in the documents the information can be found.
Regardless of whether a request for confidentiality has been submitted, certain information will always be treated confidentially
Regardless of whether a request for confidentiality has been submitted or not, certain information will not be published or disclosed.
This applies to certain information that an applicant submits in the registration report, Part C, and to personal information where disclosure of the name and address of natural persons involved in testing with vertebrate animals or obtaining toxicological information is considered to be to significant damage to the privacy and integrity of the natural persons in question, cf. Regulation art. 63(2b), d).
Exception to confidential treatment
The Danish Environmental Protection Agency may be obliged to publish or pass on information which has been granted confidential treatment or which is covered by the Regulation. 63(2b), d).
Notwithstanding the granted confidentiality,information which forms part of the conclusions of the scientific outputs delivered by the Authority and which relate to foreseeable effects on human health, animal health or the environment shall be made public, cf. the Regulation 63(2b), e), ii). In that case, Article 39c of Regulation (EC) No 178/2002 shall apply.
The Danish Environmental Protection Agency also has the right to disclose confidential information where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, cf. the Regulation, art. 63(2b), e), i).
Confidential treatment of certain information and access to information
If the Danish Environmental Protection Agency receives a request for access to information for which confidential treatment has been granted in accordance with art. 63, the Danish Environmental Protection Agency will process this request according to the applicable rules for access to information.
Even if a request for confidential treatment has never been submitted, the Danish Environmental Protection Agency will always obtain a statement from the holder of the authorisation, if the Danish Environmental Protection Agency receives a request for access to the information for which confidential treatment could have been requested.