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Table 7 Examples of legal requirements for natural substances and personal care products in the REACH, CLP and Cosmetics regulation illustrated by comments on the basis of the present study

From: Natural personal care products—analysis of ingredient lists and legal situation

(a) Examples where compliance with legal requirements needs to be improved
 Producers do not always use the INCI names Some substances can be identified if one makes the effort and compares the names with the descriptions of the origin in the INCI list
 Many natural substances are classified differently by various notifier groups (self-classification) Notifiers should find joint classifications. It is difficult for the external user to decide, which classifications are the correct ones. Even for CMR substances there are no harmonized classifications
 Many natural substances are not catalogued in the C & L inventory although they are used in products Data on classification and labelling and data on constituents are publically available only for a minor part of natural substances
 Natural substances (being UVCB substances) must only be registered according to REACH, if they meet the criteria for classification as dangerous ([20] Art. 2(7)(b) and Annex V (8)) Many natural substances are not notified in the C & L inventory yet, therefore it is not clear whether they are or should be classified and labelled and hence registered. So far only very few natural substances classified have been registered
 Manufacturers should clarify substance identities and specify all known constituents of a UVCB substance which are present above 10 % and all components which are relevant for classification with the IUPAC name, CAS number and percentage in the UVCB substance [47, 48] Only very few natural substances comply with this requirement so far. Therefore, it is hardly possible to calculate the classification of most natural substances as mixtures according to the ECHA guidance [49]
 Information should be publically available if it is ‘essential to classification and labelling,’ such as ‘the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous’ ([20] Art. 119) Toxicity of multi-constituent substances is dependent on the constituents. A proper assessment requires these data, but the publically availabe data are very scarce
 Risk assessments of single substances should consider various discharge patterns and entry paths However, the constituents of multi-constituent substances are usually not considered in risk assessments of the single substances (e.g. risk assessment of limonene does not include discharge of Citrus preparations)
 The general public should be provided with safety data sheets or sufficient information for safe handling about dangerous mixtures ([20] Art. 31) Consumers are informed only in special cases, e.g. some hair dyes about special safety arrangements. Most consumers do not expect that personal care products can be dangerous mixtures. It must be questioned whether the ingredient lists are sufficient information for safe handling
(b) Examples where natural substances and cosmetic products are granted special waivers
 Cosmetic products are not classified and labelled, even if they contain dangerous substances above the thresholds ([8] (A) Art. 1 (5)) Consumers have the right to know. This exception for cosmetic products impedes a suitable risk communication
 ‘26 fragrance allergens’ are only listed on the containers if they are added as single substances Many natural substances are mixtures that contain some of the 26 fragrance allergens as constituents, which arrive ‘incognito’ in the products
 Other mixtures—but not cosmetic products.—which are not classified as sensitizing but contain at least one sensitizing substance must be labelled with EUH208 ‘Contains (name of sensitizing substance). May produce an allergic reaction.’ ([8] Annex II Part 2 2.8) Most cosmetic products, also natural products, contain sensitizing fragrances or preservatives. Only informed persons recognize them in the ingredient lists. The label EUH208 with the two short sentences would particularly be important for personal care products. Therefore this exception should be abolished
 CMR substances may be used if their “use has been found safe by the SCCS” [22] This does not correspond to the precautionary principle in the chemical legislation and to the ‘right to know’ for the consumer. There should be no exceptions for CMR substances. They should not be allowed in personal care products, even if they are natural substances
 The chemical safety report does not need to consider the risks to human health from the use of cosmetic products ([20] Art. 14 5(b)) Realistic risk assessments should consider the complete sum of exposure routes. Exposure via personal care products is not negligible
 Data on cosmetic ingredients need not be transmitted in the supply chain ([20] Art. 2(6b)) Manufacturers and downstream users of cosmetic products should be informed like manufacturers and downstream users of any other products. This exception should be deleted to improve transparency and risk communication
 Chemical safety reports are not publicly accessible The public availablity of chemical safety reports could improve transparency [50]
 SVHCs must be authorized before they are placed on the market or used, unless they are used in cosmetic products ([20] Art. 56 (5)) With this exception for cosmetic products, authorization will affect other uses and will not enforce substitution of SVHCs in personal care products. This exception should be deleted to improve consumer and environmental protection