Examples of using Technical equivalence in English and their translations into Slovenian
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Technical equivalence.
Establishing technical equivalence;(d).
Technical equivalence' means.
Fees for the establishment of technical equivalence amount to EUR 20,000.
Technical Equivalence Assessment.
A desk officer per 20 applications for the establishment of technical equivalence;
Establishment of technical equivalence between active substances.
The data required to identify the active substance and to establish technical equivalence; .
Authorisation of biocidal products Technical equivalence In situ generated active substances.
Technical equivalence is the similarity between two active substances in regard to their chemical composition and hazard profile.
Companies can ask ECHA to establish the technical equivalence or the chemical similarity of their active substance.
ECHA will have a greater involvement in data sharing in order to avoid duplicate testing on vertebrates andwill also be called upon to take decisions regarding the"technical equivalence" of similar active substances;
To assess the technical equivalence, companies need to submit an application through R4BP 3 to ECHA.
Companies can ask the ECHA to establish the technical equivalence of their active substances.
In the assessment of technical equivalence, an active substance is compared to an already approved substance(reference active substance) to determine if they are equivalent.
The chemical similarity check is an assessment similar to the technical equivalence assessment described in Article 54 of the BPR.
If technical equivalence cannot be established based in Tier I, the applicant may ask ECHA to perform a Tier II assessment based on the hazard profile using toxicological and eco-toxicological data.
Processes aimed at facilitating data sharing between prospective applicants,at establishing technical equivalence of substances manufactured from different sources, at disseminating information, at identifying active substance manufacturers entitled to place their active substance on the Union market will also have to be improved and or developed.
Technical equivalence' means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out.
The chemical similarity check differs from the technical equivalence assessment under Article 54 of the BPR because a decision on the approval of the active substance has not yet been adopted and, therefore, the official reference source of the active substance is not yet established.
The purpose of technical equivalence is to determine the similarity with regards to the chemical composition and hazard profile, of substances produced from a source different to the reference source or from the reference source but following a change to the manufacturing process and/or manufacturing location compared to the substance of the reference source in respect of which the initial risk assessment was carried out.
The chemical similarity check differs from the technical equivalence assessment under Article 54 of the BPR because a decision on the approval of the active substance has not yet been adopted and, therefore, the official reference source of the active substance is not yet established.
Technical equivalence means similarity, as regards the chemical composition and hazard profile, between a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process or manufacturing location, and the substance from the reference source in respect of which the initial risk assessment was carried out;
Similarly, the number of expected applications for the establishment of technical equivalence has been set to 50 per year in the early years of the coming into force of the Regulation, and to 20 afterwards, as one would expect a peak of requests during these years, as companies will be expected to seek the establishment of the technical equivalence of their active substance with the one supported under the Review programme for existing active substances before starting to negotiate data sharing agreements.
The purpose of technical equivalence is to determine the similarity with regards to the chemical composition and hazard profile, of substances produced from a source different to the reference source or from the reference source but following a change to the manufacturing process and/or manufacturing location compared to the substance of the reference source in respect of which the initial risk assessment was carried out.
Without prejudice to the role of European institutions, the ESAsshould be given a certain role as regards international issues, including technical arrangements and preparation of equivalence assessments.
EMIR requires the European Securities and Markets Authority(“ESMA”) to provide technical advice to the European Commission as to the equivalence of some non-EU jurisdictions which host major derivatives markets or CCPs which have applied for recognition.
The Council may, acting by qualified majority on a proposal from the Commission,recognise the equivalence between the conditions or provisions for EU type-approval of systems, components and separate technical units laid down by this Regulation and the conditions or provisions laid down by international regulations or regulations of third countries in the framework of multilateral or bilateral agreements between the Union and third countries.
To demonstrate equivalence, tenderers can be required to provide third-party verified evidence; however, other appropriate means of proof such as a technical dossier of the manufacturer should also be allowed where the economic operator concerned has no access to such certificates or test reports, or no possibility of obtaining them within the relevant time limits.