Intellectual Property Rights Notice

1. EFSA’s IUCLID public instance
2. Extension of the EFSA Pesticide Genotoxicity Database

EFSA’s IUCLID public instance

The Authority carries out its activities with a high level of transparency and accordingly, it makes publicly available on its website information listed in Article 38 of Regulation (EC) No 178/2002 or applicable Union law, unless it is considered confidential pursuant to Articles 39-39e of Regulation (EC) No 178/2002 or applicable Union law. Certain dossiers must be submitted by means of the digital submission platform ‘International Uniform ChemicaL Information Database’ (‘IUCLID’). In such cases, the Authority’s website provides an electronic link to the dossiers published in the present website.The reproduction, distribution or further use of information, documents and data posted or otherwise made available on the present website or in websites linked to this one may be subject to protection under intellectual property rights regulations or other applicable law, and their utilisation without obtaining the prior permission from the right(s)holders(s) of the respective information, documents and data might violate the rights of the respective right(s)holder(s).

The Authority accepts no responsibility or liability, including, but not limited to, any direct or consequential loss or damage that might occur to you and/or any other third party, arising out of, or in connection with, the information made available on this website or in websites linked to this one, including information relating to documents the Authority publishes. The Authority cannot be held liable for errors, inaccuracies or inconsistencies with regard to information, documents and data available on the present website being different from the scientific and administrative documents officially adopted, issued or endorsed by the Authority. In case of disagreement between the adopted text and other versions of the document made publicly available on the website of the Authority, the adopted text will prevail.Pursuant to Article 38(1a) of the Regulation (EC) No 178/2002, disclosure by the Authority of:

• a. scientific data, studies and other information supporting applications, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion;
• b. information on which scientific outputs of the Authority, including scientific opinions, are based;
• c. a summary of the advice provided to potential applicants at pre-submission phase pursuant to Articles 32a and 32c of the Regulation (EC) No 178/2002;

is without prejudice to:

• 1. existing rules concerning intellectual property rights which set out limitations on certain uses of the disclosed documents or their content.
• 2. provisions protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations (“data exclusivity rules”).

Subject to the terms and conditions of this Legal Notice, and subject to other binding limitations provided for under applicable law, the information, documents and data made available on the present website may be downloaded and printed, totally or in part, provided that the user acknowledges the applicable conditions and, in particular, that EFSA accepts no responsibility and/or liability for any use made of the information, documents or data.

By accepting the terms and conditions of this notice, the User acknowledges that:

• a. Disclosure by EFSA of scientific data, studies and other information supporting applications, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, shall not be considered to be explicit or implicit permission or licence for the relevant data and information and their content to be used, reproduced, or otherwise exploited in breach of any intellectual property right or data exclusivity rules; and
• b. the European Union or EFSA shall not be responsible for use by third parties of scientific data, studies and other information supporting applications, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, disclosed by the Authority pursuant to Article 38 of Regulation (EC) No 178/2002 or applicable Union law; and
• c. for material subject to intellectual property rights or other rights of a third party, the User must comply with the terms of use associated with such material or obtain the necessary and written permission for reproduction, distribution or any other use from the right(s)holder; and
• d. the Authority does not accept any responsibility, and shall not be held liable, for any violation of any pre-existing rights or other infringements related to information, documents and data made available via the present website.

Extension of the EFSA Pesticide Genotoxicity Database

The publication of this database is without prejudice to existing rules concerning intellectual property rights. The reproduction, redistribution or further re-use of this database and the information contained therein may require prior authorisation from rights holders. The database contains proprietary information. The use of proprietary information for registration purposes in the EU should be in line with the regulatory data protection rules established under Article 59 of Regulation (EC) 1107/2009. It is recommended that proprietary information included in this database would not be accepted to support any registration outside the EU for which the applicant has not demonstrated that it has regulatory access to the information.EFSA does not warrant that the use of this database is error free.