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International audience; SCCS OPINION on water-soluble zinc salts used in oral hygiene products - Submission II - SCCS/1657/23 - Preliminary versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this Opinion by written procedure on 3 July 2023 (23 pages)Mise en ligne : 4 July 2023https://health.ec.europa.eu/publications/water-soluble-zinc-salts-used-oral-hygiene-products-submission-ii_enhttps://health.ec.europa.eu/system/files/2023-07/sccs_o_279.pdfDetailsPublication date : 4 July 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1657/23Adopted on: 3 July 2023Conclusion of the opinion:In light of the data provided and taking under consideration the aggregate exposure (including diet) and the concerns on the Tolerable Daily Upper Intake,(1) Does the SCCS consider that water soluble zinc salts are safe up to 1 % (as zinc) in toothpaste and 0.1% (as zinc) in mouthwash, for both adults and children? If not, the SCCS is requested to provide safe concentrations for each age group.The SCCS has calculated aggregate exposure to water-soluble zinc salts via toothpaste at the concentrations of 1% and from diet and concluded that the use of zinc in toothpaste is safe per se except for children under the age of 1 year because the intake exceeds the upper limit level. For children up to 1 year of age, the SCCS recommends a safe concentration of 0.72% for soluble zinc salts (as zinc) in toothpaste.The inclusion of zinc in mouthwash at 0.1% Zn is considered safe across all age groups.(2) Does the SCCS consider that the contribution of the cosmetic products among the overall/total exposure to zinc is still of concern?/SCCS, scientific opinion, water-soluble zinc salts, oral hygiene products, zinc acetate CAS: 557-34-6 EC: 209-170-2, zinc chloride CAS: 7646-85-7 EC: 231-592-0, zinc gluconate CAS: 4468-02-4 EC:/, zinc citrate CAS: 546-46-3 EC:/, zinc sulphate/zinc sulphate monohydrate/zinc sulphate heptahydrate CAS: 7733-02-0/7446-19-7/7446-20-0 EC:/, SCCS/1586/17, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on water-soluble zinc salts used in oral hygiene products - Submission II, preliminary version adopted on 3 July 2023, SCCS/1657/23.

International audience; Guidance on the safety assessment of nanomaterials in cosmetics - 2nd revision - SCCS/1655/23 (147 pages)U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, V. Rogiers, C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, W.H. de Jong, N. von GoetzThe SCCS adopted this document on 6 June 2023 (147 pages)Mise en ligne : 26 Juin 2023https://health.ec.europa.eu/publications/sccs-guidance-safety-assessment-nanomaterials-cosmetics-2nd-revision_enhttps://health.ec.europa.eu/system/files/2023-06/sccs_o_278.pdfDetailsPublication date : 26 June 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer (Rapporteur and Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCHEER member: W.H. de JongSCCS external experts: N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1655/23Adopted on: 6 June 2023Main changes in this revision of the SCCS guidance on the safety assessment of nanomaterials in cosmetics:● New sections have been introduced (solubility and dissolution rate, solubility in non acqueous media, evidence for the absence of nanoparticles, dispersion, aspect ratio, uptake into blood cells, reproductive toxicity, endocrine disruption),● The new European Commission recommendation for a definition of nanomaterials published in 2022 has been introduced,● Key aspects triggering safety concerns over a nanomaterial based on SCCS/1618/2020 have been introduced,● Other sections and Annex 1 have been updated based on literature that has been published since the last update,● Section on read-across and grouping has been revised.● A text explaining when historical/existing data can be used has been included.This Guidance may be subject to future changes based on the evolution of science in the field of safety assessment of nanomaterials.Keywords:SCCS, scientific opinion, nanomaterials, GuidanceOpinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Guidance on the Safety Assessment of Nanomaterials in Cosmetics, 2nd revision, 6 June 2023, SCCS/1655/23.

International audience; SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3) - SCCS/1646/22– Final OpiinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 6 June 2023 (75 Pages)Mise en ligne : 9 Juin 2023https://health.ec.europa.eu/publications/salicylic-acid-cas-no-69-72-7-ec-no-200-712-3_enhttps://health.ec.europa.eu/system/files/2023-06/sccs_o_268.pdfDetailsPublication date : 9 June 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfenati, N. Cabaton (Rapporteur), E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1646/22Adopted on: 6-7 June 2023Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Salicylic acid,a) does the SCCS consider Salicylic acid safe when used as a preservative in cosmetic products up to a maximum concentration of 0.5%?Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects:- the SCCS is of the opinion that salicylic acid (CAS 69-72-7) is safe when used as preservative at a concentration of 0.5 % in cosmetic products, considering its current restrictions in place. The provided information shows that salicylic acid is an eye irritant with the potential to cause serious damage to the eye.- this Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.b) does the SCCS consider Salicylic acid safe when used in cosmetic for purposes other than inhibiting the development of micro-organisms at a concentration up to:i. 3.0% for the cosmetic rinse-off hair products,ii. 2.0% for other products except body lotion, eye shadow, mascara, eyeliner, lipstick, non-spray deodorant, andiii. 0.5% for body lotion, eye shadow, mascara, eyeliner, lipstick, oral products and non-spray deodorantThe SCCS assessment has shown that:The use of salicylic acid as a restricted ingredient for purposes other than inhibiting the development of micro-organisms is safe at a concentration:- up to 3.0 % for the cosmetic rinse-off hair products,- up to 2.0 % for other products, except body lotion, eye shadow, mascara, eyeliner, lipstick, non-spray deodorant, and- up to 0.5% for body lotion, eye shadow, mascara, eyeliner, lipstick, oral products and non-spray deodorant.This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Salicylic acid in cosmetic products? / (3) Does the SCCS have any further scientific concerns with regard to the use of Salicylic acid in cosmetic products? In the absence of exposure data of Salicylic acid in cosmetic products for children, safety concerns have been noted for the younger age groups (between 3-10 years).Since the Cosmetic Regulation does not allow the use of salicylic acid in products for children under 3 years of age, this age category has not been considered in this Opinion.The conclusions of this Opinion refer only to Salicylic Acid as a cosmetic ingredient and not to other salicylates or salicylic acid salts.Keywords:SCCS, scientific opinion, salicylic acid, Regulation 1223/2009, CAS No. 69-72-7, EC No. 200-712-3Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3), preliminary version of 14 December 2022, final version of 6-7 June 2023, SCCS/1646/22.

International audience; SCCS OPINION on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7) - SCCS/1652/23– Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this document during its plenary meeting on 6-7 June 2023 2023 (95 pages)Mise en ligne : 8 Juin 2023https://health.ec.europa.eu/publications/methylparaben-cas-no-99-76-3-ec-no-202-785-7_enhttps://health.ec.europa.eu/system/files/2023-06/sccs_o_276.pdfDetailsPublication date : 8 June 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1652/23Adopted on: 6-7 June 2023Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Methylparaben, does the SCCS consider Methylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.4% (as acid) when used on its own and up to 0.8% (as acid) for mixtures of esters as indicated in entry 12 of Annex V to the Cosmetics Regulation?On the basis of the safety assessment of Methylparaben, and considering the concerns related to potential endocrine activity, the SCCS has concluded that Methylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.4% (as acid) when used on its own and up to 0.8% (as acid) for mixtures of esters as indicated in entry 12 of Annex V to the Cosmetics Regulation.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Methylparaben as a preservative in cosmetic products?/(3) Does the SCCS have any further scientific concerns with regard to the use of Methylparaben in cosmetic products?The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Methylparaben for the environment.Keywords:SCCS, scientific opinion, methylparaben, preservative, Regulation 1223/2009, CAS No. 99-76-3, EC No. 202-785-7Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7), preliminary version of 6-7 June 2023, SCCS/1652/23.

International audience; SCCS OPINION on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - SCCS/1651/23– Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this document during its plenary meeting on 6-7 June 2023 2023 (136 pages)Mise en ligne : 8 Juin 2023https://health.ec.europa.eu/publications/butylparaben-cas-no-94-26-8-ec-no-202-318-7_enhttps://health.ec.europa.eu/system/files/2023-06/sccs_o_275.pdfDetailsPublication date : 8 June 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1651/23Adopted on: 6-7 June 2023Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Butylparaben, does the SCCS consider Butylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %?On the basis of safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Butylparaben as a preservative in cosmetic products?/(3) Does the SCCS have any further scientific concerns with regard to the use of Butylparaben in cosmetic products?In the absence of solid exposure data for children to Butylparaben in cosmetic products, potential safety concerns have been noted by the SCCS.The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Butylparaben for the environment.Keywords:SCCS, scientific opinion, butylparaben, preservative, Regulation 1223/2009, CAS No. 94-26-8, EC No. 202-318-7Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on butylparaben (CAS No. 94-26-8, EC No. 202-318-7), preliminary version of 6-7 June 2023, SCCS/1651/23.

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Acid Yellow 3 – C054 (CAS Number 8004-92-0, EC No 305-897-5), submission II, preliminary version of 7 May 2021, final version of 23 July 2021, SCCS/1631/21.

International audience; SCCS OPINION ON Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes (nano) - SCCS/1649/23 - Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, M. Stepnik, S. Wijnhoven, W.H. de Jong, N. von GoetzThe SCCS adopted this document at its plenary meeting on 21-22 Mach 2023Mise en ligne : 24 Avril 2023 (87 pages)https://health.ec.europa.eu/system/files/2023-04/sccs_o_271_0.pdfhttps://health.ec.europa.eu/publications/fullerenes-hydroxylated-fullerenes-and-hydrated-forms-hydroxylated-fullerenes-nano_enPublication date : 24 April 2023Author : Scientific Committee on Consumer Safety (SCCS)Description : SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri (Rapporteur), M. Stepnik, S. WijnhovenSCHEER members: W.H. de JongSCCS external experts: N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1649/23Adopted on: 21-22 March 2023Conclusion of the opinion:(1) In view of the above, and taking into account the scientific data provided, does the SCCS consider Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes safe when used in cosmetic products according to the maximum concentrations and specifications as reported via CPNP, taking into account reasonably foreseeable exposure conditions?Having assessed the information provided by the Notifiers, and the information available from published literature, the SCCS has not been able to conclude on the safety of fullerenes and (hydrated) hydroxylated forms of fullerenes due to a number of uncertainties and data gaps in regard to physicochemical, toxicokinetic and toxicological aspects. These uncertainties and data gaps have been indicated in relevant sections of the Opinion and must be addressed by the Notifiers to enable a conclusion on the safety of the materials for use in cosmetic products.In particular, the SCCS has not been able to conclude on the genotoxicity potential of fullerenes (C60 and C70). The available evidence indicates that hydrated forms of hydroxylated fullerenes are genotoxic and hence SCCS considers them as not safe for use in cosmetic products. In view of equivalence as discussed before (see section 3.1.1.5), the same concerns over genotoxicity potential also apply to hydroxylated fullerenes.(2) Based on the currently available scientific literature and SCCS’ expert judgement, the SCCS is requested to assess any further scientific concerns with regard to the use of Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes in cosmetic products and whether a potential risk to human health can be identified according to Article 16(6) Reg.1223/2009.In Annex-1 of this Opinion, the SCCS has noted the basis for concerns over risks that the use of fullerenes, hydroxylated fullerenes and hydrated forms of hydroxylated fullerenes in cosmetic products may pose to the consumer. In brief, the SCCS has a concern in regard to:− the potential presence of impurities, heavy metals, accompanying contaminants and/or organic solvents in the notified nanomaterials. Lack of data on stability of hydroxylated fullerenes and their hydrated forms.− the potential ability of fullerenes and derivatives to induce production of free oxyradicals when used in cosmetic products.− phototoxicity of hydroxylated fullerenes – with similar concerns for the hydrated forms of hydroxylated fullerenes.− sensitising potential of hydroxylated fullerenes.− dermal absorption and systemic availability of the nanoparticles after use in cosmetic products.− distribution of systemically available fullerenes to various organs in the body and potential accumulation of the nanoparticles in certain organs – such as lungs and liver.− the available information does not allow the SCCS to exclude genotoxic/carcinogenic potential of any of the materials assessed in this Opinion.Keywords:SCCS, scientific opinion, Fullerenes, Hydroxylated Fullerenes, hydrated forms of Hydroxylated Fullerenes, nano, CAS/EC No. 99685-96-8/628-630-7, 11538-22-7/-, 182024-42-6/-, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes (nano), preliminary version of 21-22 March 2023, SCCS/1649/23.

International audience; SCCS Opinion on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0) - SCCS/1650/23 - Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri , V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 21-22 March 202 (36 Pages)Mise en ligne : 4 Avril 2023https://health.ec.europa.eu/publications/silver-zinc-zeolite-cas-no-130328-20-0-ec-no-603-404-0_enhttps://health.ec.europa.eu/system/files/2023-04/sccs_o_270.pdfDetailsPublication date : 4 April 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson and Rapporteur), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1650/23Adopted on: 21-22 March 2023Conclusion of the opinion: (1) In light of the data provided and taking under consideration the classification as Toxic for reproduction Cat. 2, does the SCCS consider Silver Zinc Zeolite safe when used as a preservative in cosmetic products according to the specifications and concentration limits provided in the dossier submission?The SCCS considers that Silver Zinc Zeolite (CAS No. 130328-20-0) incorporating a maximum silver content of 2.5% is safe in spray deodorant and powder foundation when used at the proposed concentration of 1%.(2) Alternatively, what is, according to the SCCS, the maximum concentration considered safe for use of Silver Zinc Zeolite as a preservative in cosmetic products? /(3) Does the SCCS have any further scientific concerns with regard to the use of Silver Zinc Zeolite in cosmetic products? /Keywords:SCCS, scientific opinion, silver zinc zeolite, Regulation 1223/2009, CAS No. 130328-20- 0, EC No. 603-404-0Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on silver zinc zeolite (CAS No. 130328-20- 0, EC No. 603-404-0), preliminary version of 21 March 2023, SCCS/1650/23.

International audience; SCCS OPINION ON Hydroxyapatite (nano) - SCCS 1648/22 – Final OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, M. Stepnik, S. Wijnhoven, W.H. de Jong, N. von GoetzThe SCCS adopted this document at its plenary meeting on 21 and 22 March 2023 (47 Pages)Mise en ligne 23 Mars 2023https://health.ec.europa.eu/publications/hydroxyapatite-nano-0_enhttps://health.ec.europa.eu/system/files/2023-03/sccs_o_269.pdfDetailsPublication date23 March 2023AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska (Rapporteur), E. Gaffet, E. Panteri, M. Stepnik, S. WijnhovenSCHEER external experts: W.H. de JongSCCS external experts: N. von GoetzContact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1648/22Adopted on: 21-22 March 2023Conclusion of the opinion:(1) In view of the above, and taking into account the scientific data provided, does the SCCS consider hydroxyapatite (nano) safe when used in oral cosmetic products according to the maximum concentrations and specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions?Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash.This safety evaluation only applies to the hydroxyapatite (nano) with the following characteristics:- composed of rod-shaped particles of which at least 95.8% (in particle number) have an aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9;- the particles are not coated or surface modified.Does the SCCS have any further scientific concerns with regard to the use of hydroxyapatite (nano) in oral cosmetic products?This Opinion is not applicable to hydroxyapatite (nano) composed of needle-shaped particles.Although the use of hydroxyapatite (nano) is indicated also for breath spray, no data were provided to allow assessment of consumer safety from inhalation exposure. Therefore, this Opinion is not applicable to sprayable products that might lead to exposure of the consumer’s lungs to nanoparticles by inhalation.Keywords:SCCS, scientific opinion, Hydroxyapatite, HAP, nano, CAS/EC No.: 1306-06-5/215-145-7, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Hydroxyapatite (nano), preliminary version 4 January 2023, final version 21-22 March 2023, SCCS/1648/22.

International audience; SCCS OPINION on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) - SCCS/1645/22 - Final VersionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 21 and 22 March 2023 (47pages)Mise en ligne 23 Mars 2023 https://health.ec.europa.eu/publications/sccs-sodium-bromothymol-blue-c186-cas-no-34722-90-2-ec-no-252-169-7_enhttps://health.ec.europa.eu/system/files/2023-03/sccs_o_267.pdfDetailsPublication date23 March 2023AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1645/22Adopted on: 21-22 March 2023Conclusion of the opinion:In light of the data provided, does the SCCS consider Sodium Bromothymol Blue safe when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5 %?Having considered the data provided, the SCCS is of the opinion that the safety of sodium bromothymol blue cannot be assessed because of the following reasons:- The Applicant used TTC approach to justify the safety of sodium bromothymol blue, but the SCCS estimate of the SED indicates that it exceeds the TTC threshold for Cramer class III substances.- The use of TTC on its own to justify the safety of the substances that are regulated under the EU Cosmetic Regulation is not sufficient to waive the information requirements on essential toxicological endpoints.2. Does the SCCS have any further scientific concerns with regard to the use of Sodium Bromothymol Blue in cosmetic products?While the use of TTC is acceptable to justify the safety of impurities and cosmetic ingredients that are added to a final product at sufficiently low concentrations, it is not acceptable on its own for the substances that ar regulated under the EU Cosmetic Regulation. Additional supporting data from NAMs that are scientifically-accepted for the purpose, and/or other acceptable in vivo data on systemic toxicity, are also required in an overall weight of evidence to assess safety.Keywords:SCCS, scientific opinion, sodium bromothymol blue, C186, hair dye, Regulation 1223/2009, CAS No. 34722-90-2, EC No. 252-169-7Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on sodium bromothymol blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7), preliminary version of 24-25 October 2022, final version of 21-22 March 2023, SCCS/1645/22

International audience; SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final Opinion and CorrigendumU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 21 and 22 March 2023 (62 Pages)Mise en ligne : 23 Mars 2023https://health.ec.europa.eu/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_enhttps://health.ec.europa.eu/system/files/2023-03/sccs_o_266_0.pdfDetailsPublication date2 February 2023AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)Contact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1644/22Adopted on: 1 February 2023A corrigendum has been adopted on 21 March 2023 adding a note explaining that “AP” means “antiperspirant” under Table 6 of the Applicant.Conclusion of the opinion:1. In light of the new data provided, does the SCCS consider Aluminium compounds safe when used in cosmetic products other than deodorants, antiperspirants, lipsticks and toothpastes? In the event that the estimated exposure to Aluminium from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for each category.The SCCS considers that aluminium compounds are safe when used-in non-sprayable product categories at the maximum levels indicated in Tables 4 and 6; and- in sprayable products, at the maximum levels indicated in Table 4, provided that the percentage of particles/droplets with a diameter of less than 10 μm does not exceed 20% of the total aerosolised particles/droplets. Since the Applicant’s data submission indicated that aluminium is not used in sunscreen aerosol sprays, this Opinion does not cover sunscreen aerosol sprays.2. Does the SCCS have any further scientific concerns regarding the use of relevant Aluminium compounds in cosmetic products taking into account the newly submitted information on aggregate exposure to Aluminium from cosmetics, medicines (e.g. antacids) and food intake?As aluminium does not belong to substances classified as CMR 1A or B, only exposure from cosmetic uses was considered in this safety assessment with the exposure assessment based on maximum use levels for cosmetic ingredients.However, the submission also provided a scenario where realistic exposure from non-cosmetic sources of aluminium (food and pharmaceuticals) was aggregated along with exposure from cosmetics at use levels from the year 2016. From this scenario, it can be deduced that contribution to aluminium exposure from food may be at a similar order of magnitude to that from cosmetics used for the safety assessment. Considering the conservative nature of the estimates, the aggregate exposure to aluminium from cosmetic and non-cosmetic sources may exceed safe limits for consumers at the highest exposure ranges.Keywords:SCCS, revision, scientific opinion, aluminium, submission III, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products - Submission III, preliminary version of 6 May 2022, final version of 1 February 2023, Corrigendum 21 March 2023, SCCS/1644/22

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on HAA299 (nano), preliminary opinion July 22, 2021, final opinion 26–27 October 2021, SCCS/1634/2021. HAA299 is a UV filter active intended to be used in sunscreen products as skin protectant against UVA-1 rays. Its chemical name is ‘2-(4-(2-(4-Diethylamino-2 hydroxy-benzoyl)-benzoyl)-piperazine-1-carbonyl)-phenyl)-(4-diethylamino-2-hydroxyphenyl)-methanone’ and INCI name ‘Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine’ (CAS 919803-06-8). This product was designed and developed to deliver to the consumer stronger UV protection on skin and is most effective as a UV filter when it is milled to a smaller particle size, a process we refer to as micronization. Currently HAA299 normal form and nano form is not regulated under the Cosmetic Regulation (EC) No. 1223/2009. In 2009, Commission' services received a dossier from industry to support the safe use of HAA299 (micronised and non-micronised) in cosmetic products, which was further substantiated with additional information in 2012. In its corresponding opinion (SCCS/1533/14), the SCCS concluded that “the use of non-nano HAA299 (micronised or non-micronised, with median particle size distribution around 134 nm or larger, as measured by FOQELS) at a concentration up to 10% as an UV-filter in cosmetic products, does not pose a risk of systemic toxicity in humans”. In addition, SCCS stated that “[the Opinion] … covers the safety evaluation of HAA299 in non-nano form. The opinion does not cover the safety evaluation of HAA299 which is composed of nano particles' and highlighted that ‘[the Opinion] … does not apply to inhalation exposure of HAA299 since no information on chronic or sub-chronic toxicity after inhalation is provided”. With the current submission, received in September 2020, and in view of the previous SCCS opinion (SCCS/1533/14) on the normal form of HAA299, the applicant requests to assess the safety of HAA299 (nano) intended to be used as UV-filter up to a maximum concentration of 10%.

International audience; SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 1st Februray 2023 (60 Pages)Mise en ligne : 2 February 2023https://health.ec.europa.eu/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_enhttps://health.ec.europa.eu/system/files/2023-02/sccs_o_266.pdfDetailsPublication date 2 February 2023Author Scientific Committee on Consumer Safety (SCCS)Description SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)Contact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1644/22Adopted on: 1 February 2023Conclusion of the opinion:1. In light of the new data provided, does the SCCS consider Aluminium compounds safe when used in cosmetic products other than deodorants, antiperspirants, lipsticks and toothpastes? In the event that the estimated exposure to Aluminium from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for each category.The SCCS considers that aluminium compounds are safe when used-in non-sprayable product categories at the maximum levels indicated in Tables 4 and 6; and- in sprayable products, at the maximum levels indicated in Table 4, provided that the percentage of particles/droplets with a diameter of less than 10 μm does not exceed 20% of the total aerosolised particles/droplets. Since the Applicant’s data submission indicated that aluminium is not used in sunscreen aerosol sprays, this Opinion does not cover sunscreen aerosol sprays.2. Does the SCCS have any further scientific concerns regarding the use of relevant Aluminium compounds in cosmetic products taking into account the newly submitted information on aggregate exposure to Aluminium from cosmetics, medicines (e.g. antacids) and food intake?As aluminium does not belong to substances classified as CMR 1A or B, only exposure from cosmetic uses was considered in this safety assessment with the exposure assessment based on maximum use levels for cosmetic ingredients.However, the submission also provided a scenario where realistic exposure from non-cosmetic sources of aluminium (food and pharmaceuticals) was aggregated along with exposure from cosmetics at use levels from the year 2016. From this scenario, it can be deduced that contribution to aluminium exposure from food may be at a similar order of magnitude to that from cosmetics used for the safety assessment. Considering the conservative nature of the estimates, the aggregate exposure to aluminium from cosmetic and non-cosmetic sources may exceed safe limits for consumers at the highest exposure ranges.Keywords:SCCS, revision, scientific opinion, aluminium, submission III, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products - Submission III, preliminary version of 6 May 2022, final version of 1 February 2023, SCCS/1644/22

International audience; SCCS (Scientific Committee on Consumer Safety), scientific opinion on Butylated hydroxytoluene (BHT), preliminary version of September 27, 2021, final version of December 2, 2021, SCCS/1636/21.

International audience; SCCS OPINION on Genistein and Daidzein - SCCS/1641/22 Final versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 16 September 2022 (153 pages)Mise en ligne 23 Septembre 2022https://health.ec.europa.eu/publications/genistein-and-daidzein_enDetailsPublication date : 23 September 2022Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer (Rapporteur Daidzein), L. Bodin, Q. Chaudhry (Rapporteur Genistein), P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli (Rapporteur Genistein), B. Granum (former member), E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur Daidzein), M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1641/22Adopted on: 16 September 2022Conclusion of the opinion: (1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of phytoestrogens,(a) does the SCCS consider genistein safe when used in cosmetic products up to a maximum concentration of 0.007%?(b) does the SCCS consider daidzein safe when used in cosmetic products up to a maximum concentration of 0.02%?From the safety assessment based on the available relevant data on the aglycone form of genistein and daidzein, and in consideration of the potential endocrine disrupting properties of phytoestrogens, the SCCS considers that:a) the use of genistein (CAS No 446-72-0, EC No 207-174-9) in cosmetic products up to a maximum concentration of 0.007% is safe.b) the use of daidzein (CAS No 486-66-8, EC No 207-635-4) in cosmetic products up to a maximum concentration of 0.02% is safe. (2) Alternatively, according to the SCCS what is the maximum concentration of genistein and daidzein that is considered safe for individual and combined use in cosmetic products?/(3) Does the SCCS have any further scientific concerns with regard to the use of genistein and daidzein or other related phytoestrogens in cosmetic products?/Keywords:SCCS, scientific opinion, genistein (CAS No 446-72-0, EC No 207-174-9), daidzein (CAS No 486-66-8, EC No 207-635-4), Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Scientific opinion on genistein and daidzein, preliminary version of 12 January 2022, final version of 16 September 2022, SCCS/1641/22.

International audience; SCCS OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5) - Submission II - SCCS/1631/21 – Final OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 23 July 2021 (31 Pages)Mise en ligne le 26 Juillet 2021 https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_253.pdfConclusion of the opinion: (1) In light of the data provided, does the SCCS consider Acid Yellow 3, safe when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5 %?Based on the data provided in the dossier, the SCCS considers that Acid Yellow 3 is safe when used in non-oxidative hair colouring products at on-head concentrations of up to 0.5%.(2) Does the SCCS have any further scientific concerns with regard to the use of Acid Yellow 3 in cosmetic products?A detailed analytical report on the test substance in representative batches and results of the stability tests should be provided to exclude the possibility of the presence of any impurities that may be of concern.Keywords:SCCS, scientific opinion, Acid Yellow 3, hair dye, Regulation 1223/2009, CAS Number 8004-92-0, EC No 305-897-5Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Acid Yellow 3 – C054 (CAS Number 8004-92-0, EC No 305-897-5), submission II, preliminary version of 7 May 2021, final version of 23 July 2021, SCCS/1631/21.

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Acid Yellow 3 - C054 (CAS Number 8004-92-0, EC No 305-897-5), submission II, preliminary version of 7 May 2021, final version of 23 July 2021, SCCS/1631/21.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) IMI 507028 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 109 colony forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 109 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘High risk plants, plant products and other objects’). This Scientific Opinion covers plant health risks posed by 1‐ to 3‐year‐old dormant grafted plants and rootstocks of Malus domestica imported from Ukraine, taking into account the available scientific information, including the technical information provided by Ukraine. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Two quarantine pests (Lopholeucaspis japonica and Tobacco ringspot virus), one protected zone quarantine pest (Erwinia amylovora) and one non‐regulated pest (Eotetranychus prunicola) that fulfilled all relevant criteria were selected for further evaluation. For Erwinia amylovora, for which special requirements are specified in Commission Implementing Regulation (EU) 2019/2072, Annex X, item 9, the fulfilment of these requirements was evaluated. Based on the information provided in the dossier, the specific requirements for Erwinia amylovora were not met. For the three remaining selected pests, the risk mitigation measures proposed in the technical dossier from Ukraine were evaluated taking into account the possible limiting factors. For the selected pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with Eotetranychus prunicola being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation indicated with 95% certainty that between 9,912 and 10,000 bundles (consisting of 50 plants each) per 10,000 would be free from Eotetranychus prunicola.

International audience; SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 6 May 2022 (51 Pages)Mise en ligne 30 Mai 2022https://ec.europa.eu/health/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_enDescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)Contact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1644/22Adopted on: 6 May 2022Conclusion of the opinion:1. In light of the new data provided, does the SCCS consider Aluminium compounds safe when used in cosmetic products other than deodorants, antiperspirants, lipsticks and toothpastes? In the event that the estimated exposure to Aluminium from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for each category.The SCCS considers that aluminium compounds are safe when useda. in non-sprayable product categories at the maximum levels indicated in Table 4;andb. in sprayable antiperspirant products, provided that the maximum percentage of particles with 10 μm diameter does not exceed 20% of the total aerosolised particlesThe SCCS could not assess safety of aluminium compounds in sprayable applications other than antiperspirant. These applications (including eau de toilette, eau de parfum and hair spray) are therefore excluded from this Opinion.2. Does the SCCS have any further scientific concerns regarding the use of relevant Aluminium compounds in cosmetic products taking into account the newly submitted information on aggregate exposure to Aluminium from cosmetics, medicines (e.g. antacids) and food intake?As aluminium does not belong to substances classified as CMR 1A and B, only exposure from cosmetic uses was considered in this safety assessment.However, in a scenario provided by the Applicant, where exposure from non-cosmetic sources of aluminium (food and pharmaceuticals) was aggregated with exposure from cosmetics, food contributed in a similar order of magnitude as cosmetics. The aggregate exposure to aluminum from cosmetic and non-cosmetic sources may therefore exceed safe limits.Keywords:SCCS, revision, scientific opinion, aluminium, submission III, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products - Submission III, preliminary version of 6 May 2022, SCCS/1644/22

The EFSA Panel on Plant Health performed a pest categorisation of Maconellicoccus hirsutus (Hemiptera: Pseudococcidae), the pink hibiscus mealybug, for the EU. M. hirsutus is native to Southern Asia and has established in many countries in tropical and subtropical regions throughout the world. Within the EU, the pest has been reported from Cyprus and Greece (Rhodes). M. hirsutus is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is highly polyphagous, feeding on plants assigned to 229 genera in 78 plant families, and shows some preference for hosts in the families Malvaceae, Fabaceae and Moraceae. Economically important crops in the EU such as cotton (Gossypium spp.), citrus (Citrus spp.), ornamentals (Hibiscus spp.), grapes (Vitis vinifera), soybean (Glycinae max), avocado (Persea americana) and mulberry trees (Morus alba) may be significantly affected by M. hirsutus. The lower and upper developmental temperature threshold of M. hirsutus on Hibiscus rosa‐sinensis are 14.5 and 35.0°C, respectively, with optimal female development estimated to be at 29.0°C. There are about 10 generations a year in the subtropics but as many as 15 may occur under optimal conditions. Plants for planting, fruits, vegetables and cut flowers provide potential pathways for entry into the EU. Climatic conditions in EU member states around the Mediterranean Sea and host plant availability in those areas are conducive for establishment. The introduction of M. hirsutus is expected to have an economic impact in the EU through damage to various ornamental plants, as already observed in Cyprus and Greece, and reduction in yield and quality of many significant crops. Phytosanitary measures are available to reduce the likelihood of entry and further spread. Some uncertainties include the area of establishment, whether it could become a greenhouse pest, impact, and the influence of natural enemies. M. hirsutus meets the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest.

International audience; Publication date10 May 2022Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, B. Granum, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1640/21Adopted on: 29 April 2022Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of 4-Methylbenzylidene camphor (4-MBC), does the SCCS consider 4-MBC safe when used as a UV-filter in cosmetic products up to a maximum concentration of 4%?The SCCS cannot conclude on the safety of 4-MBC, because the information provided is insufficient to fully evaluate potential genotoxicity.Moreover, there is sufficient evidence that 4-MBC may act as an endocrine disruptor and has effects on both the thyroid and estrogen systems. Effects on the androgen system are not so evident, as only in vitro evidence is available.Even if the genotoxic potential was excluded, the current re-evaluation of 4-MBC established a higher exposure level than in the previous Opinion. This would result in a lower MoS value, indicating that the use of 4-MBC at the maximum concentration of 4% in cosmetic ingredients would not be safe.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of 4-MBC as a UV-filter in cosmetic products?It is not possible to derive a maximum concentration for safe use of 4-MBC, because a genotoxicity potential cannot be excluded.(3) Does the SCCS have any further scientific concerns with regard to the use of 4-MBC in cosmetic products?The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of 4-MBC for the environment.Keywords:SCCS, revision, scientific opinion, 4-Methylbenzylidene camphor (4-MBC), CAS No 36861-47-9/38102-62-4, EC No 253-242-6, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on 4-Methylbenzylidene camphor (4-MBC), preliminary version of 22 December, final version of 29 April 2022, SCCS/1640/21.

International audience; SCCS OPINION on the safety of alpha-arbutin and beta-arbutin in cosmetic products - SCCS/1642/22 – Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 15 and 16 March 2022 (70 Pages)Mise en ligne 26 Mars 2022https://ec.europa.eu/health/publications/safety-alpha-arbutin-and-beta-arbutin-cosmetic-products_en DetailsPublication date25 March 2022AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1642/22Adopted on: 15-16 March 2022Conclusion of the opinion: (1) In light of the data provided, does the SCCS consider α-arbutin safe when used in face creams up to a maximum concentration of 2% and in body lotions up to a maximum concentration of 0.5 %?Having considered the data provided, and other relevant information available in scientific literature, the SCCS cannot conclude on the safety of alpha-arbutin when used in face creams up to a maximum concentration of 2% and in body lotions up to a maximum concentration of 0.5%. Relevant data on the degradation/metabolism of alpha-arbutin, exposed to the skin microbiome/enzymes, are not available and the release of hydroquinone and its final fate are not documented. These data are essentially required for safety assessment.(2) In the event that the estimated exposure to α-arbutin from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits.For the reasons given under question 1, the SCCS cannot recommend a safe concentration of alpha-arbutin.(3) In light of the data provided, does the SCCS consider β-arbutin safe when used in face creams up to a maximum concentration of 7%?No information was provided during the call for data. The SCCS has, therefore, considered the information available in scientific literature but regarded it insufficient to conclude on the safety of beta-arbutin when used in face cream up to a maximum concentration of 7%. Also, relevant data on the fate of beta-arbutin, when applied to human skin and its microbiome/enzymes, are not available and the release of hydroquinone and its final fate are not documented.(4) In the event that the estimated exposure to β-arbutin from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits.For the reasons given under question 3, the SCCS cannot recommend a safe concentration of beta-arbutin.(5) In light of the data provided, does the SCCS consider that the presence of hydroquinone in the cosmetic formulations must remain below 1 ppm for both α- and β arbutin containing products?Hydroquinone should remain as low as possible in formulations containing alpha-or beta arbutin and should not be higher than the unavoidable traces in both arbutins. In the new studies, submitted by the applicant, 3ppm was the LOQ/LOD of the methodology used.(6) Does the SCCS have any further scientific concerns regarding the use of a- and β arbutin in cosmetic products in relation to aggregate exposure from such substances in cosmetics?Safe concentrations for either of the arbutins in cosmetic products cannot be established without the data on the release of hydroquinone and their final fate.Keywords:SCCS, scientific opinion, alpha-arbutin, beta-arbutin, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of alpha- (CAS No. 84380-018, EC No. 617-561-8) and beta-arbutin (CAS No. 497- 76-7, EC No. 207-8503) in cosmetic products, preliminary version of 15-16 March 2022, SCCS/1642/22

International audience; SCCS Opinion on Kojic Acid - SCCS/1637/21 - Final versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 15 and 16 March 2022 (85 Pages)Mise en ligne 17 Mars 2022https://ec.europa.eu/health/publications/kojic-acid_enDescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. WijnhovenSCCS external experts: A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1637/21Adopted on: 15-16 March 2022Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Kojic acid, does the SCCS consider Kojic acid safe when used in cosmetic products up to a maximum concentration of 1 %?On the basis of the safety assessment, and considering the concerns related to potential endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that Kojic acid is not safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Kojic acid in cosmetic products?In the SCCS’s opinion, the use of Kojic acid as a skin lightening agent in cosmetic products is safe for the consumer up to a maximum concentration of 0.7% Kojic acid in the final product.(3) Does the SCCS have any further scientific concerns with regard to the use of Kojic acid in cosmetic products?As Kojic acid is sometimes added to peeling agents, a weakened skin barrier may be of additional concern because of greater dermal absorption.Only the topical use of Kojic acid in cosmetics has been considered in this Opinion. Other uses (e.g. food) of natural or synthetic sources have not been considered.As far as the derivatives of Kojic acid are concerned, e.g. esters of Kojic acid such as Kojic acid dipalmitate and Kojic acid isopalmitate, and derivatives such as chloro-Kojic acid, these have not been included in this Opinion as no data has been submitted.Keywords:SCCS, revision, scientific opinion, Kojic acid, CAS No 501-30-4, EC No 207-922-4, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on Kojic acid, preliminary version of 26-27 October 2021, final version of 15-16 March 2022, SCCS/1637/21.

International audience; SCCS OPINION on Prostaglandins and their analogues used in cosmetic products - SCCS/1635/21 - Final versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 3 February 2022 (41 pages)Mise en Ligne 4 February 2022https://ec.europa.eu/health/publications/prostaglandins-and-prostaglandin-analogues-used-cosmetic-products_enAuthorDirectorate-General for Health and Food SafetyDescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik (Rapporteur), T. Vanhaecke, S. WijnhovenSCCS external experts: A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1635/21Adopted on: 3 Februrary 2022Conclusion of the opinion: (1) In light of the data provided, does the SCCS consider Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide or DDDE (CAS 1185851-52-8) safe when used up to the concentrations provided in the respective dossiers (0.006% and 0.007% for Isopropyl cloprostenate and 0.018% for Ethyl Tafluprostamide)Having considered the limited data provided and the available information from published literature, the SCCS is not able to conclude on the safety of isopropyl cloprostenate and ethyl tafluprostamide when used up to the intended use concentrations indicated in the respective dossiers (0.006% and 0.007% for isopropyl cloprostenate and 0.018% for ethyl tafluprostamide).(2) Does the SCCS have any further scientific concerns with regard to the use of Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide / DDDE (CAS 1185851-52-8) in cosmetic products?The SCCS has noted concerns about the safety of isopropyl cloprostenate and ethyl tafluprostamide when used in cosmetic products - in particular those that are intended for use in the proximity of the eye. These concerns have been highlighted in more detail in Annex 1.(3) In light of the available data, does the SCCS consider that the use in cosmetic products of prostaglandins analogues (listed in Table 1) raises safety concerns and might pose a risk to human health?Prostaglandins and synthetic analogues are widely known to be potent pharmacologically active substances. Due to these effects, other regulatory authorities have advised against, or have prohibited, their use in eyelash growth-promoting cosmetics. In view of the potential for causing effects at very low concentrations, and the intended use in the proximity of the eye, the SCCS has noted concerns over the safety of prostaglandin analogues when used in cosmetic products. These have been highlighted in Annex 1 to this Opinion.Keywords:SCCS, scientific opinion, prostaglandins, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Prostaglandins and prostaglandin-analogues used in cosmetic products, preliminary version of 27 September 2021, final version of 3 February 2022, SCCS/1635/21.

This article also appears in: Animal Health Law: Assessment of the control measures of the category A diseases of terrestrial animals., EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases (‘Animal Health Law’). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for Contagious Caprine Pleuropneumonia (CCPP). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period, (iii) the minimum radius of the protection and surveillance zones and iv) the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. Different clinical and laboratory sampling procedures are proposed depending on the scenarios considered. The monitoring period of 45 days was assessed as effective in affected areas where high awareness is expected, and when the index case occurs in an area where the awareness is low the monitoring period should be at least 180 days (6 months). Since transmission kernels do not exist and data to estimate transmission kernels are not available, a surveillance zone of 3 km was considered effective based on expert knowledge, while a protection zone should also be developed to include establishments adjacent to affected ones. Recommendations, provided for each of the scenarios assessed, aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to CCPP., European Commission: EFSA-Q-2020-0080

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on hydrothermally treated kernels from edible Jatropha curcas (Chuta) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Although Jatropha curcas is generally considered a toxic plant due to the presence of phorbol esters (PEs), edible varieties exist in Central America. The applicant has developed a breeding programme for an edible cultivar and proposes the kernels from this cultivar as an NF as whole kernels or fragments thereof to be used as a snack or as a food ingredient. Procedures are in place to avoid commingling with non‐edible kernels, with the last steps being the analytical control of PEs concentrations in all produced batches. The Panel considers that the production process of the NF is sufficiently described and that the information provided on the composition of the NF is sufficient for its characterisation. Components of the NF were tested for genotoxicity applying the standard in vitro test battery and no genotoxic concerns have been identified. In a conservative scenario for exposure to PEs from the NF, it was assumed that all kernels contain PEs at the level of detection of the analytical method. When comparing the estimated maximum exposure to PEs with a reference point from a subchronic study in pigs, a margin of exposure ≥ 900 is obtained, which is considered sufficiently large. The presence of anti‐nutritional factors does not pose safety concerns as they are within the ranges found in vegetables. The Panel concludes that the NF is safe under the proposed conditions of use.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of two rosemary extracts obtained from the ■■■■■ of Rosmarinus officinalis L., as a technological (antioxidant) feed additive for cats and dogs. The two rosemary extracts were obtained through two different solvent extraction methods, acetone and ethanol. The additives were specified to contain carnosic acid and carnosol as the reference antioxidative compounds at a minimum content of their sum as ≥ 10% in the case of the acetone extract and ≥ 5% for the ethanol extract. Based on the data available, the FEEDAP Panel concluded that the maximum safe concentrations of the additives in feed were 300 and 50 mg/kg feed, for dogs and cats, respectively. No data on potential effects on respiratory system were available; however, as the products are in liquid form, the FEEDAP Panel considered that the exposure through inhalation is unlikely. The additives were shown to be irritant to skin and consequently they were considered also eye irritants. Due to the lack of data, the FEEDAP Panel cannot conclude on the potential of the additives to be skin sensitisers. The food and feed matrices in which the additives are intended to be used are of comparable nature. Therefore, the antioxidant effect observed when the additives are used in food is expected to be observed also when the additives are used in feed at the recommended concentrations.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process DENTIS RECYCLING Italy (EU register number RECYC226), which uses the Starlinger iV+ technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried and crystallised in a first reactor, then extruded into pellets. These pellets are crystallised, preheated and treated in a solid‐state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the drying and crystallisation (step 2), extrusion and crystallisation (step 3) and SSP (step 4) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air flow and residence time for the drying and crystallisation step, and temperature, pressure and residence time for the extrusion and crystallisation step as well as the SSP step. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Biffa Waste Services (EU register number RECYC225), which uses the Starlinger iV+ technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried and crystallised in a first reactor, then extruded into pellets. These pellets are crystallised, preheated and treated in a solid‐state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the drying and crystallisation (step 2), extrusion and crystallisation (step 3) and SSP (step 4) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air flow and residence time for the drying and crystallisation step, and temperature, pressure and residence time for the extrusion and crystallisation step as well as the SSP step. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

The food enzyme rennet containing chymosin (EC 3.4.23.4) and pepsin (EC 3.4.23.1) is prepared from the abomasum (stomach) of suckling lambs, by Productos Nievi, SA. The food enzyme is intended to be used in milk processing for cheese production. As no concerns arise from the animal source of the food enzyme, from its manufacture, and based on the history of safe use and consumption, the Panel considered that toxicological data were not required and no exposure assessment was necessary. On the basis of literature data, the Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure could not be excluded, but the likelihood for this to occur was considered to be low. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law’). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for glanders. In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radius of the protection and surveillance zone, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere. Considering the epidemiology and distribution of glanders, it was foreseen that three different situations could lead to a suspicion of the disease. Sampling procedures were defined for each of the three different suspicion types, which can also be applied in most of the other scenarios assessed. The monitoring period (6 months) was assessed as effective in all scenarios. The AHAW Panel of experts considered the minimum radius and duration of the existing protection and surveillance zone, set at the establishment level, effective. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to glanders.