Annex IV — CONFORMITY ASSESSMENT PROCEDURE, REFERRED TO IN ARTICLE 8(2)

Module A – Internal production control 1. Description of the module Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 3 and 4, and ensures and declares on its sole responsibility that the detergent or surfactant concerned is in conformity with this Regulation. 2. Technical documentation 2.1. The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess compliance of the detergent or surfactant with the relevant requirements and shall include an adequate analysis and assessment of the risks. 2.2. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and intended use of the detergent or surfactant. The technical documentation shall contain at least the following elements: (a) a general description of the detergent or surfactant; (b) where applicable, the test reports demonstrating compliance with Annexes I and II and the report of the risk assessment referred to in point 7 of Annex II; (c) where applicable, a list of test methods used to demonstrate compliance with this Regulation; (d) results of calculations made, including to demonstrate compliance with the limit values set out in Annexes II and III, where applicable, and examinations carried out; (e) an ingredients data sheet which contains: (i) the name or trade name of the detergent or surfactant, the unique formula identifier, the name, registered trade name or registered trade mark of the manufacturer and the intended use of the detergent or surfactant; (ii) the list of all intentionally added substances; for the purposes of such a list, a perfume, an essential oil or a colouring agent shall be considered to be a single component, and preservatives and fragrance allergens shall also be listed if they must be labelled in accordance with Regulation (EC) No 1272/2008 or (EU) No 528/2012 or with Part A, points 1(h)(iii) and (iv), of Annex V to this Regulation. All substances shall be identified in accordance with Article 18(2) of Regulation (EC) No 1272/2008. However, an International Nomenclature of Cosmetic Ingredients name, a colour index name or another international chemical name may be used, provided the chemical name is well known and unambiguously defines the substance identity. The chemical name of substances for which an alternative chemical name has been allowed in accordance with Article 24 of that Regulation shall also be provided. However, the generic component identifiers perfumes or colouring agents may be used for ingredients used exclusively to add perfume or colour, provided that the following conditions are met: the ingredients are not classified for any health hazard, the concentration of ingredients identified with a given generic component identifier does not exceed, in total, 5 % for the sum of perfumes and 25 % for the sum of colouring agents. All substances shall be listed in order of decreasing abundance by weight, and the list is sub-divided into the following weight percentage ranges, unless the manufacturer opts for providing the exact concentration: (1) ≥ 25 – < 100; (2) ≥ 10 – < 25; (3) ≥ 1 – < 10; (4) ≥ 0,1 – < 1; (5) > 0 – < 0,1; (iii) where applicable, a list of all intentionally added micro-organisms providing their taxonomic classification (genus, species and strain name or code), the deposition accession number of each microbial strain at an IDA, and the standard plate count of the micro-organisms in the detergent, expressed in CFUs per millilitre or gram of product; (iv) the pH, if available, of the mixture, or where the product is a solid, the pH of an aqueous liquid or solution at a given concentration; the concentration of the test mixture in water shall be indicated; if the pH is not available, the reasons shall be given; (v) a specimen of the label of the detergent or surfactant in accordance with Article 17. 3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the detergent or surfactant with the technical documentation referred to in point 2. 4. Digital product passport The manufacturer shall create the digital product passport for each model of detergent or end-user surfactant and ensure that, together with the technical documentation, it remains available for 10 years after the detergent or end-user surfactant has been placed on the market. The digital product passport shall identify the detergent or end-user surfactant for which it has been drawn up. The manufacturer shall also ensure that the technical documentation of other surfactants remains available for 10 years, where applicable.