a. Under this SOW, UL will:
(i) Provide ECHA UUID and API key relating to ChemADVISOR Europe SRL, for the purpose of Client submitting Client’s product information dossier via UL software to the ECHA system as required for poison centre notification under regulation EC 1272/2008 (“CLP”) in the European Union (EU). The parties agree and acknowledge that UL may delegate performance of any or all Services to UL's Affiliate, ChemADVISOR Europe SRL.
(ii) Provide a brief quality review of a sampling of Client’s product information dossiers, with such sampling to be determined by UL, prior to Client’s submission of Client’s product information dossier to the ECHA system. UL will report issues to Client for Client to rectify prior to submission. The brief quality review of the sampling will include a review of:
- (1) Product name
- (2) Reference number
- (3) Unique Formula Identifier (UFI) codes
- (4) Consistency of hazard classification and hazard labelling elements according to CLP regulation
- (5) Confirming the UL legal entity information entered is correct, including the UUID/API key
- (6) Confirming the contact person is identified and completed with Client contact details/ information
- (7) Confirming the notification is marked as a Voluntary Submission as defined by the regulation
- (8) Confirming the SDS classification matches the classification in the notification
- (9) Confirming which Member States and languages are being notified
(iii) Notify Client when brief quality review is completed, and Client may then proceed with submissions.
(iv) Retain a log of the information and results of the brief quality review relating to Client’s product information dossiers reviewed, including the date of review, outcomes and the information identified in part 1(a)(ii) above.
(v) UL has the right to periodically check the ChemADVISOR Europe SRL legal entity ECHA account to audit the number of product information dossiers submitted by Client under ChemADVISOR Europe SRL legal entity. If an audit reveals that Client’s submission has exceeded the number permitted under this SOW, UL shall be permitted to invoice Client fees for their actual usage of the Services.
b. Standard Process:
- (i) UL shall provide ECHA UUID and API key to Client.
- (ii) Client shall prepare the product information dossiers and notify UL that they are ready for brief quality review. Client will provide a full list of reference numbers identifying which product information dossiers are to be notified. Client will not submit product information dossiers until UL provides written agreement to proceed.
- (iii) UL shall perform a brief quality review of a sampling of product information dossiers and notify Client of any issues.
- (iv) Client will rectify any issues within product information dossiers and notify UL.
- (v) UL may choose to re-review the product information dossiers.
- (vi) UL will notify Client in writing with agreement to proceed when UL’s brief quality review criteria have been met.
- (vii) Client will submit product information dossiers via UL software to ECHA system.
2. Client Responsibilities
- (a) Client shall be responsible for any notification fees that may be applicable.
- (b) Client shall create Unique Formula Identifier (UFI) codes for each product as relevant.
- (c) Client shall be responsible for the compilation, accuracy, and completeness of the product information dossier, make updates as required by law, and notify UL when product information dossiers are ready for brief quality review. Client will provide full list of reference numbers identifying which product information dossiers are to be notified.
- (d) Client will cooperate fully, including providing a contact person and contact details, and provide any responses to inquiries in accordance with the timeframes specified by the regulatory authority, government agency, government body, applicable administrative body, or other duly appointed third party.
- (e) Client will provide any other information reasonably requested by UL.
- (f) Client shall provide access to Client’s UL software instance for UL specialists to perform the brief quality review.
- (g) Client shall submit product information dossiers to the ECHA system, upon receipt of UL’s agreement to proceed.
- (h) Client shall indemnify UL, its Affiliates, and their personnel against damages, fines, losses, and reasonable expenses resulting from third party claims (including a governmental action or investigation) or liabilities arising out of the invalidity, inaccuracy or incompleteness of information provided by Client to a regulatory authority or UL.
a. Any Services or phases of work not explicitly detailed in this SOW are subject to a separate mutually agreed SOW. For clarity, these Services do not include:
- (i) Product testing, verification of Client-provided information, or review or approval of Client derivative works based on the Services. Any derivative works are the sole responsibility of the Client.
- (ii) Handling inquiries or requests from Client’s customers, suppliers or affiliates unless specifically identified in the applicable SOW.
- (iii) Recommendations regarding laboratory testing facilities.
- (iv) Appointment of UL as an Only Representative (or equivalent role, where relevant) unless specifically identified in the applicable SOW.
- (v) Template formatting, rule writing, regulatory mapping work, regulatory data loading, label design, or the review or preparation of Exposure Scenarios, extended Safety Data Sheets or SUMI, unless specifically identified in the applicable SOW.
- (vi) UL providing services, support or information relating to emergency response, or technical inquiries from a regulatory authority, government agency, government body, applicable administrative body, or other duly appointed third party.