Transcript CPNP
CPNP Health & Consumers Directorate General 1 Brussels, 13 April 2015 AGENDA Scope of CPNP Article 13 (notification of products) Article 16 (notification of nanomaterials) Roles into CPNP Registration mechanism (ECAS & SAAS) Administration interfaces for a Local Admin Accept/Reject access requests submitted by colleagues Give Local Admin rights to colleague(s) Block/Delete existing accounts 2 AGENDA Presentation of Art. 13 Notification by a Responsible Person Notification by a distributor (Art. 13(3)) Presentation of Art. 16 (Nanomaterials notification) Search Mechanisms Simple Search Advanced Search Upcoming changes – Evolution and maintenance Support provided by the EC ? 3 SCOPE OF CPNP 4 Legal basis The CPNP is the online notification system created for the implementation of Articles 13 and 16 of Regulation (EC) No 1223/20091 of the European Parliament and of the Council on cosmetic products. The responsible persons and, under certain circumstances, the distributors of cosmetic products shall submit through the CPNP some information about the products they place or make available on the European market. The CPNP is making available electronically some of the above mentioned information to the Competent Authorities (for the purposes of market surveillance, market analysis, evaluation and consumer information) and to the Poison Centres or similar bodies established by Member States (for the purposes of medical treatment). 5 Article 13 (notification of products) As from 11 January 2012, Responsible Person had the possibility to notify through CPNP, by way of derogation from Directive 76/768/EEC, the information referred to in Article 13(1) and (2) of Regulation (EC) No 1223/2009. As from 11 July 2013, the use of CPNP became mandatory. As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, must submit into CPNP the information referred to in Article 13(3) of Regulation (EC) N° 1223/2009. 6 Article 16 (notification of nanomaterials) In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person 6 months prior to being placed in the market, except where they have already been placed on the market by the same responsible before 11 January 2013 7 ROLES INTO CPNP 8 Responsible Persons (RP) They can create/update and notify products. A Responsible Person can only edit/consult his own notifications. Mechanism in place for Responsible Persons willing to delegate the notification of (a part of) their products. 9 Distributors (DIS) Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes available in another Member State a cosmetic product already placed on the market in a Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law 10 Delegate (DEL) Art 16 : the responsible person may designate another legal or natural person by written mandate for the notification of nanomaterials and shall inform the Commission thereof. This role needs to be selected at the moment of registration In each notification the delegate needs to indicate for which RP he will enter information A delegate can lock some tabs of the notification – this locked information is not visible to the RP. The tab ‘Quantity’ is not visible to the delegate A delegate cannot fully notify to the Commission If there is a request for additional information, the delegate also needs to reply to this request 11 Poison Information Centres (PIC) Any body established by member States and who can access the CPNP portal for the purposes of medical treatment. They can consult all the details of the notifications submitted by Responsible Persons (and Distributors). Draft notifications are not accessible to Poison Centres. 12 Competent Authorities (CA) In charge of market surveillance, market analysis, evaluation and consumer information regarding cosmetic products. They can consult all the details of the notifications submitted by Responsible Persons (and Distributors), except their composition. Draft notifications are not accessible to Competent Authorities. 13 REGISTRATION MECHANISM 14 ECAS: Create a personal account (1) • ECAS: European Commission Authentication Service • This system provides the user with a login and password to connect to multiple European Commission applications. • Remark: Please do not create generic accounts. • URL: https://webgate.ec.europa.eu/aida/selfreg 15 ECAS: Create a personal account (2) 16 ECAS: Create a personal account (3) 17 ECAS: First login (1) • URL: https://webgate.ec.europa.eu/cpnp 18 ECAS: First login (2) 19 SAAS: Request an access to CPNP (1) • SAAS: SANCO Authentication and Authorisation System • This system provides the user with a profile and access rights for a specific European Commission application, in this case the CPNP. • Remark: SAAS provides also administration interfaces to the Local Admin. • URL: https://webgate.ec.europa.eu/saas 20 SAAS: Request an access to CPNP (2) Select your organisation or create it yourself (if missing) You can also create your own suborganisation, for instance if you want to delegate the notification of your products to sub-contractors. Please, when creating a suborganisation, do not forget to select the right « parent » organisation 21 SAAS: Request an access to CPNP (3) Please, select ONLY one option: Responsible Person, Distributor or Delegate Click on this button to validate your choice. 22 SAAS: common mistakes Missing access profile: Please, do not forget to indicate the desired access profile in your request. Many access profiles: You can request one, and only one, access profile. Mix of access profiles: All the members of an organisation (and its sub-organisations) must have the same profile. Organisation details are missing: When creating a new organisation, please provide all the information (Name, Address, City, Postal code, Country and Phone). 23 ADMINISTRATION INTERFACES FOR A LOCAL ADMIN 24 Requested/active/locked access profiles List of pending access requests, submitted by you (and still under validation) List of all current active profiles that you have on CPNP Direct link to the administration interfaces (for Local Admin only) List of all your rejected access requests, with the reason of the reject 25 Accept/reject an access request List of pending access requests, submitted for your organisation. You can accept requests for the access profiles you have yourself. If you reject a request, you must specify the reason of your reject. List of all requests already rejected (with reason of the reject) 26 Lock/delete an existing account Lock or delete an existing account Edit the details of the access profile (see next slide) 27 Give Local Admin rights You have the possibility to grant access only for a limited period Flag to be checked if you want to also grant Local Admin rights. 28 PRESENTATION OF ART. 13 29 PRESENTATION OF ART. 16 30 Fill out form / reply to request for extra information Fill out form / reply to request for extra information Delegate RP Send to RP Notify to Commission / Reply to Commission Complete form / complete reply to request for extra information Yes Check notification RP Commission Notify to Commission / Reply to Commission Yes Reply to SCCS Extra info needed? Check notification Yes Commission No Yes Concern? No Notification is stored and can still be changed to ‘Concern’ Reply to SCCS Extra info needed? Yes No Assess dossier Concern? SCCS Yes Extra info needed? Assess dossier SCCS No Extra info needed? Give opinion No Give opinion 31 No Notification is stored and can still be changed to ‘Concern’ SEARCH MECHANISMS 32 Simple Search “Instant” search: results list is refreshed automatically. Search on product/component name, RP/distributor name, category level 3 and CPNP reference Possibility to exports results in XLS or PDF format Highlighting Pagination mechanism 33 Advanced Search Other search criteria also in the second tab. You can combine several search criteria 34 UPCOMING CHANGES 35 Before end of 2013 - Evolutive maintenance New environment for PICs and CAs Improvement of the notification form (single <-> multi-components products) Possibility to export more than 100 products Exchange mechanism between PICs/CAs and RP Summary of releases Performance improvements 36 January 2014 - Updated frame formulations New set of Categories (Level 1 – 3) Frame Formulations Triggered Questions Valid for all new the products, and in case of update/correction of products already notified in the system. 37 Maintenance group A Maintenance Group has been set up, with representatives of The Industry The Competent Authorities The Poison Centres Regular meetings (bi-annual) Also in charge of the regular update of the Frame Formulations 38 SUPPORT 39 Support provided by the EC Regulation (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT CPNP AND OF THE COUNCIL on cosmetic products: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2009R1223:20130711 :en:PDF FAQ : https://webgate.ec.europa.eu/cpnp/faq Registration Tutorial: https://webgate.ec.europa.eu/cpnp/public/tutorial.cfm User’s Manual Translations: http://ec.europa.eu/consumers/sectors/cosmetics/cpnp/index_en.htm SCCS Guidance on Nanomaterials: http://ec.europa.eu/health/scientific_committees/consumer_safety/do cs/sccs_s_005.pdf Material also available on CPNP website, under the tab Useful links (user manual, list of categories and frames, …) 40 Support provided by the EC External systems ECAS (lost password): https://webgate.ec.europa.eu/cas/help.html CosIng - European Commission database with information on cosmetic substances and ingredients: http://ec.europa.eu/consumers/cosmetics/cosing/ Technical support Please consult first the FAQ In case of necessity, you can contact the Support Team by completing the online form (in the FAQ) Mails sent to the functional mailbox are not treated 41 Thank you for your attention ! CPNP (Official): https://webgate.ec.europa.eu/cpnp CPNP (Training): https://webgate.acceptance.ec.europa.eu/cpnp Functional Mailbox: [email protected] 42