#news Tag

Cosmetics:

EU to set labelling requirement for 56 additional fragrances in cosmetic products.

The European Commission is planning an amendment to the cosmetics Regulation that will set a labelling requirement for an additional 56 fragrance allergens.

The changes, set out in a European Commission draft amendment, mean cosmetic products in the EU must list on their labels 81 allergenic chemicals found in fragrances or essential oils if they are present at levels greater than 0.001% for leave-on products or 0.01% for rinse-off products.

The new substances, derived from synthetic fragrances, include;

  • menthol;
  • terpineol;
  • linalyl acetate;
  • camphor;
  • vanillin; and
  • geraniol derivatives (geranial and geranyl acetate).

The newly added substances also include some natural essential oils/extracts such as ylang ylang oil (cananga odorata flower oil), cinnamon oil (cinnamomum zeylanicum bark oil) and lavender oil (lavandula officinalis flower oil).

The amendment offers companies a transition period of three years from when the amendment takes effect to reformulate their products and comply. However, it also gives five years for the withdrawal of non-compliant products.

Currently, 25 cosmetic fragrance ingredients, listed in Annex III of the cosmetics Regulation, must be included in the list of product ingredients on cosmetics packaging, while all other fragrances can be listed as “parfum” or “aroma”.

The draft amendment follows a 2012 Opinion by the Scientific Committee on Consumer Safety (SCCS) that identified the additional 56 allergens, which have caused allergies in humans and have currently no requirement of individual labelling.

The Commission is expected to open the amendment for feedback soon, after which it is expected to be adopted in the first half of 2023, according to a WTO notification.

 

ECHA

Commission bans 14 CMRs under EU cosmetic products Regulation.

New concentration limits for uses of methyl salicylate

The European Commission has banned 14 carcinogenic, mutagenic or toxic for reproduction (CMR) chemicals from being used in cosmetic products.

A Commission amending Regulation, dated 15 September, has added the chemicals to the prohibited substances list under Annex II of the cosmetic products Regulation.

The banned CMRs include:

  • tetrafluoroethylene;
  • 3-methylpyrazole;
  • 4-methylpentan-2-one oxime;
  • 6,6′-di-tert-butyl-2,2′-methylenedi-p-cresol; and
  • methyl isobutyl ketone.

The ban will come into force on 17 December and cover all cosmetic products on the EU market, imported and EU-made. It marks the fifth annual update to the Commission Regulation restricting and/or prohibiting the use of CMR substances in cosmetic products.

Methyl salicylate

The amending Regulation also introduces new restrictions on the use of methyl salicylate, an ingredient in many fragrance mixtures and oral hygiene products.

The European Commission’s Scientific Committee on Consumer Safety (SCCS) concluded in October that the substance is safe when used in cosmetic products up to set maximum concentrations.

However, the SCCS pointed out that methyl salicylate is also used in other consumer products, such as household cleaning items, so combined exposure could exceed safe levels.

Therefore, the use of methyl salicylate will be restricted as follows:

  • up to 0.06% in leave-on skin products (except face make-up, spray/aerosol body lotion, spray/aerosol deodorant, and hydroalcoholic-based fragrances) and leave-on hair products (except spray/aerosol products);
  • up to 0.05% in face make-up (except lip products, eye make-up and make-up remover);
  • up to 0.002% in eye make-up and make-up remover;
  • up to 0.009% in leave-on hair products spray/aerosol;
  • up to 0.003% in deodorant spray/aerosol;
  • up to 0.4% in body lotion spray/aerosol;
  • up to 0.06% in rinse-off skin products (except hand wash) and rinse-off hair products;
  • up to 0.6% in hand wash, hydroalcoholic-based fragrances, and mouthwash intended for children above 10 years of age and adults;
  • up to 0.03% in lip products;
  • up to 2.52% in toothpaste;
  • up to 0.1% in mouthwash intended for children aged 6-10 years; and
  • up to 0.65% in mouth spray.

Methyl salicyclate is banned from use in cosmetic products for children under six. The only exception is toothpaste.

 

REACH

European Commission adopts authorisation decision for use of 4-tert-OPnEO

EU executive permits application of the endocrine disruptor in pharmaceuticals

The European Commission has adopted a REACH authorisation decision granting a specific use of the SVHC 4-tert-OPnEO.

In an EU Official Journal entry on 13 September, the EU executive announced it has permitted Pfizer Manufacturing Belgium use of the chemical – also known as 4-(1,1,3,3-tetra methylbutyl)phenol, ethoxylated – as a surfactant within a lubricant used in the manufacture of pharmaceutical drug products.

The review period runs until 4 January 2030. The Commission said it granted permission for this use because it believes the socio-economic benefits outweigh the risk to human health and the environment from the uses of the substance, and that suitable alternative substances or technologies do not exist.

The substance is listed on the REACH Annex XIV authorisation list for its endocrine disrupting properties affecting the environment. The latest application date for 4-tert-OPnEO was 4 July 2019, and it had a sunset date of 4 January 2021.

In March, in its parallel UK REACH legislation, the Department for Environment, Food and Rural Affairs (Defra) approved an application for a use of the substance.

At the EU level, the Commission has been working on plans to reform the authorisation process under REACH as part of its wide-ranging chemicals strategy for sustainability.

Pharma

QSAR Toolbox extension broadens possibilities for animal-free chemicals assessment

The new add-on helps users to predict chemical properties, including endocrine activity, while avoiding testing on animals.

The OPERA extension contains models for predicting properties that are important for assessing chemical hazards. The extension can be used to screen chemical databases to identify substances that may cause endocrine disruption. It also helps users to estimate acute oral toxicity and other regulatory relevant properties.

Developed by the US National Institute of Environmental Health Sciences (NIEHS), OPERA can predict properties related to the absorption, distribution and metabolism of substances that can strengthen read-across justifications and facilitate the regulatory use of in vitro test results.

The extension can be downloaded for free from the QSAR Toolbox Repository.

REACH:

Assessment of substance group published

A new report is now available for Acyl glycinates and sarcosinates.

ECHA submitted a proposal to restrict per- and polyfluoroalkyl substances (PFAS) in firefighting foams in early 2022.

 

CLP:

New proposals and intentions to harmonise classification and labelling.

New intentions have been received for:

  • eugenol; 4-allyl-2-methoxyphenol (EC 202-589-1, CAS 97-53-0);
  • 2,3-epoxypropyl o-tolyl ether(EC 218-645-3, CAS 2210-79-9); and
  • Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene; Reaction products of diphenylamine with nonene, branched (EC -, CAS -).

Two proposals have been submitted for:

 

Hazardous substances:

Updates on toys regulation.

Two decrees transposing two Commission directives amending Directive 2009/48/EC on the safety of toys have been published in the Italian Official Journal. The amendments concern the ban on the use and labelling of allergenic fragrances in toys.

In particular, the decree transposing Directive 2020/2088/EU replaces the entry on citronellol and adds 61 new allergenic fragrances. In detail, the names of the allergenic fragrances shall be indicated on the toy, on the label, on the packaging and in the instructions attached to the toy, if present and added as such in the toy in concentrations greater than 100 mg/kg of the toy or its components.

 

ECHA:

Nine proposals to identify new substances of very high concern.

The substances and examples of their uses are:

  • 4,4′-sulphonyldiphenol (bisphenol S; BPS) (EC 201-250-5, CAS 80-09-1). The substance is used for the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals.
  • Perfluoroheptanoic acid and its salts (EC -, CAS -). The substances are not registered under REACH.
  • Melamine (EC 203-615-4, CAS 108-78-1). The substance is used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals.
  • Isobutyl 4-hydroxybenzoate (EC 224-208-8, CAS 4247-02-3). The substance is used in the manufacture of substances and in coating products, fillers, putties, plasters, modelling clay, and inks and toners.
  • Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (EC -, CAS -). The substance is used as a flame retardant and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives.
  • Barium diboron tetraoxide (EC 237-222-4, CAS 13701-59-2). The substance is used in paints and coatings.
  • Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine (FC-770) (EC 473-390-7, CAS -). The substance is used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.
  • 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol (tetrabromobisphenol-A; TBBPA) (EC 201-236-9, CAS 79-94-7). The substance is used as a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles.
  • 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] (EC 253-692-3, CAS 37853-59-1). The substance is not registered under REACH.

 

REACH:

Modified recommendations to registrants on how to cover mutagenicity information requirements.

ECHA’s Member State Committee (MSC) agreed to modify the approach for investigating chromosomal aberration under REACH dossier evaluation during its June meeting.

The main changes include:

To fulfil REACH Annex VIII 8.4.2 requirements, an in vitro micronucleus study (OECD Test Guideline 487) is the default test as it allows the mode of action (clastogenicity and/or aneugenicity) to be identified.

If a concern for chromosomal aberration is identified in vitro, a follow-up study combining an in vivo comet assay (OECD Test Guideline 489) and an in vivo micronucleus test (OECD Test Guideline 474) will be needed in most cases.

Recommendations to registrants have been modified to reflect these changes, which have applied since 1 September 2022.

The European Commission has granted an authorisation for the use of sodium chromate (EC 231-889-5, CAS 7775-11-3) to Ariston Thermo SpA with a review period expiry date on 26 August 2033.

 

Biocides:

Have your say: EFSA and ECHA guidance on the impact of water treatment processes on active substance residues in drinking water.

ECHA has collaborated with the European Food Safety Authority (EFSA) to launch a consultation on a draft guidance on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water.

The deadline for comments is 27 October 2022.

New report on European arthropods and their role in pollination 

A report has been published describing the biodiversity and the ecology of four insect orders: Diptera, Lepidoptera, Coleoptera and Hymenoptera, covering the majority of flower visiting insects. The report focuses on the sensitivity of these organisms to biocidal products.

 

SDS:

Publication of the updated version of the Guideline “SAFETY DATA SHEETS” – Part 4.

How to evaluate the (e)SDS and decide the subsequent actions” and the “Tool to verify compliance with exhibition scenarios” in the light of the changes that REACH has made in recent years to the format and content of the Safety Data Sheets and following the changes introduced by the latest revision of the ECHA Guidelines on descriptors.

 

Source: https://echa.europa.eu/it/information-on-chemicals

Agrochemical:

  • Glyphosate: no change proposed to hazard classification

ECHA’s Committee for Risk Assessment (RAC) agrees to keep glyphosate’s current classification as causing serious eye damage and being toxic to aquatic life. Based on a wide-ranging review of scientific evidence, the committee again concludes that classifying glyphosate as a carcinogen is not justified.

https://echa.europa.eu/it/-/glyphosate-no-change-proposed-to-hazard-classification

REACH:

  • Assessments of two substance groups published.

Assessments of regulatory needs are now available for:

Methylene diphenyl ureas; and Aralkylamines

https://echa.europa.eu/it/assessment-regulatory-needs?utm_source=echa-weekly&utm_medium=email&utm_campaign=weekly&utm_content=20220601&_cldee=tg0Kup3vx6_GlvuqZTICneBIo83xMR9d74aNqTQv0mfoJZqqRQF5iZbcKxRm4IXcOJFnsT_NfrOK-z3YfvJ_-g&recipientid=lead-67c0fcd4c0e0e71180fa005056952b31-948887e921a44a9db97c5ca582fa4681&esid=3f5e0192-84e1-ec11-813c-005056b9310e

  • Consolidated texts for UK REACH and CLP laws published

https://chemicalwatch.com/484152/consolidated-texts-for-uk-reach-and-clp-laws-published

Nanomaterials:

  • Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices

https://euon.echa.europa.eu/nanopinion/-/blogs/urinary-microrna-based-early-cancer-detection-using-nanowire-based-devices?_cldee=tg0Kup3vx6_GlvuqZTICneBIo83xMR9d74aNqTQv0mfoJZqqRQF5iZbcKxRm4IXcOJFnsT_NfrOK-z3YfvJ_-g&recipientid=lead-67c0fcd4c0e0e71180fa005056952b31-948887e921a44a9db97c5ca582fa4681&esid=3f5e0192-84e1-ec11-813c-005056b9310e

Cosmetics:

  • Danish Consumer Council exposes ‘undesirable’ substances in sunscreen products

https://chemicalwatch.com/493607/danish-consumer-council-exposes-undesirable-substances-in-sunscreen-products

Food:

  • Efsa issues final list of plasticisers in FCMs prioritised for risk assessment

https://chemicalwatch.com/486442/efsa-issues-final-list-of-plasticisers-in-fcms-prioritised-for-risk-assessment

 

Biocidi:

  • DECISIONE DI ESECUZIONE (UE) 2022/323 DELLA COMMISSIONE del 22 febbraio 2022 relativa alle obiezioni irrisolte riguardanti le condizioni per il rilascio dell’autorizzazione del biocida Sojet conformemente al regolamento (UE) n. 528/2012 del Parlamento europeo e del Consiglio

https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2022&codLeg=86917&parte=1%20&serie=S2

 

REACH:

  • Upcoming changes to REACH information requirements:

The European Commission has revised certain information requirements for registering chemicals under REACH. Companies should start to prepare as the changes will begin to apply in October 2022. ECHA will publish further advice later this year.

https://echa.europa.eu/it/-/upcoming-changes-to-reach-information-requirements-1

  • Group assessment of bisphenols identifies need for restriction:

ECHA and the Member States have assessed a group of 148 bisphenols and recommended that more than 30 bisphenols need to be restricted due to their potential hormonal or reprotoxic effects.

https://echa.europa.eu/it/-/group-assessment-of-bisphenols-identifies-need-for-restriction

  •     Five substances added to REACH Authorisation List

Companies that want to continue using these substances after the agreed sunset dates will need to apply for authorisation. The Authorisation List now contains 59 entries.

The five substances are:

  • Tetraethyllead (TEL) (EC 201-075-4, CAS 78-00-2);
  • 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol [with ≥ 0.1% w/w of Michler’s ketone (EC 202-027-5) or Michler’s base (EC 202-959-2)] (EC 209-218-2, CAS 561-41-1);
  • Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥ 0,1% w/w 4-heptylphenol, branched and linear (4-HPbl)] (EC -, CAS -);
  • 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) (EC 239-622-4, CAS 15571-58-1); and
  • Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE) (EC -, CAS -).

https://echa.europa.eu/it/-/five-substances-added-to-reach-authorisation-list

 

Food:

  • Salmonella e Campylobacter continuano a presentare elevati livelli di resistenza agli antibiotici

La resistenza agli antibiotici nei batteri Salmonella e Campylobacter è ancora elevata, si afferma in un rapporto pubblicato oggi dal Centro europeo per la prevenzione e il controllo delle malattie (ECDC) e dall’Autorità europea per la sicurezza alimentare (EFSA).

https://www.efsa.europa.eu/it/news/salmonella-and-campylobacter-continue-show-high-levels-antibiotic-resistance

  • L’EFSA e l’ECDC indagano su un focolaio epidemico plurinazionale di Salmonella legato ad alcuni prodotti a base di cioccolato.

Si sta evolvendo rapidamente in sette Paesi UE/SEE e nel Regno Unito (UK) un focolaio epidemico di Salmonella Typhimurium, variante monofasica. A partire dal 5 aprile 2022 sono stati segnalati 134 casi, soprattutto tra bambini di età inferiore a 10 anni. Il primo caso è stato individuato nel Regno Unito il 7 gennaio 2022. Dal 17 febbraio 2022 in poi sono stati individuati casi anche in altri luoghi d’Europa.

https://www.efsa.europa.eu/it/news/efsa-and-ecdc-investigate-multi-country-salmonella-outbreak-linked-chocolate-products

 

Chemical:

  • EU adopts ‘great detox’ roadmap to ban thousands of chemicals

https://chemicalwatch.com/469632/eu-adopts-great-detox-roadmap-to-ban-thousands-of-chemicals

 

CLP:

Pubblicazione del 18° Adeguamento al Progresso Tecnico e Scientifico (ATP) del CLP

E’ stato pubblicato il Regolamento Delegato (UE) 2022/692 che modifica l’Allegato VI del Regolamento CLP, comprendente una lista di sostanze con classificazione ed etichettatura armonizzata. Il 18° ATP si applica alle sostanze e alle miscele a decorrere dal 23 novembre 2023, anche se è possibile anticiparne volontariamente l’adozione.

CLP:

Ad hoc consultation on harmonised classification and labelling of glyphosate

The proposal for the harmonised classification and labelling of glyphosate (EC 213-997-4, CAS 1071-83-6) was proposed by Sweden and subject to a consultation, which ended on 22 November 2021.

Meanwhile, new articles potentially relevant to the classification of the substance have been published. They concern to the following hazard classes:

  • respiratory sensitisation,
  • specific target organ toxicity – single exposure (respiratory irritation),
  • germ cell mutagenicity,
  • carcinogenicity,
  • reproductive toxicity, and
  • hazardous to the aquatic environment.

ECHA is looking for comments related to these.

The deadline for comments is 12 April 2022.

 

Biocides:

Guidance on human health information requirements updated

We have published an update to the guidance document for the Biocidal Products Regulation (BPR) Volume III – Human Health – Information Requirements (Part A). The update aligns the guidance with the new information requirements of the BPR (Annexes II and III) amended by Regulation (EU) 2021/525, which will enter into force on 15 April 2022.

 

QSAR:

QSAR Toolbox updated

The web client of the QSAR Toolbox has been updated, simplifying its use. The new functionalities contain the possibility to run QSAR models or access the details of study results.

The OECD QSAR Toolbox is a freely available software for animal-free evaluation of chemical substances. It has over 25 000 users worldwide from regulatory authorities, industry, academia, and non-governmental entities. The Toolbox is co-developed by ECHA and the OECD.

 

EU PFAS restriction will have ‘very limited’ derogations, says dossier submitter:

An EU restriction dossier for a universal ban on per- and polyfluoroalkyl substances (PFASs) will have “very limited” derogations even without essential use criteria contained in it, the project lead at the Dutch National Institute for Public Health and the Environment (RIVM) has said.

The comments from one of five European competent authorities jointly preparing the dossier come after a European Commission official established last week that the restriction would not incorporate essential use because criteria would not be ready in time, even though the Montreal Protocol concept was first pictured, in the context of chemicals, for a ban on PFASs

 

Cosmetics:

European Commission begins consulting on cosmetics Regulation revision

The European Commission has begun public consultation on the targeted revision of the EU cosmetic products Regulation, which is set to introduce significant changes to the law.

It opened on 29 March and will regard five measures under consideration. They are:

·         the generic risk assessment (GRA) approach, which would automatically ban the most hazardous chemicals and only allow their use if they are found to be essential to society;

·         a new measure to account for combination effects from exposure to chemicals from different sources;

·         a review of the definition of nanomaterials;

·         improving the labelling information on cosmetic products; and

·         streamlining the scientific assessment of cosmetic products by integrating the Scientific Committee on Consumer Safety (SCCS) into Echa.

The consultation is based off of a questionnaire and is for all relevant stakeholders, ranging from EU citizens to professional users of cosmetics, industry associations, civil society organisations, and member state authorities, including those involved in customs and market surveillance.

REACH:

Resorcinol to be added to REACH candidate list after long battle

The European Commission has won its battle over the identification of resorcinol as an SVHC based on endocrine disrupting properties for human health, after its controversial draft Decision narrowly won the backing of EU member states.

Riorganizzazione degli Uffici

La Direzione Generale dei Dispositivi Medici e del servizio Farmaceutico (DGDMF) sta andando incontro ad una riorganizzazione degli Uffici e ad una revisione del proprio protocollo che comporterà l’invio di ogni comunicazione inerente i PMC e i biocidi all’Ufficio 8 (Biocidi e cosmetici) e non più all’Ufficio 1 (Affari generali e prodotti di interesse sanitario diversi dai dispositivi medici).

 

Nuove modalità di redazione e trasmissione dei provvedimenti

A partire dall’ 8 marzo 2022 i provvedimenti inerenti i PMC e i biocidi, come quelli di autorizzazione all’immissione in commercio di biocidi e PMC o di autorizzazione alla produzione di PMC e le relative modifiche, rilasciati dall’Ufficio 8 secondo il Regolamento (UE) 528/2012 ed il D.P.R. 6 ottobre 392/1998, sono firmati digitalmente. I documenti così formati, costituenti i provvedimenti autorizzativi o di modifica di autorizzazione, verranno trasmessi via posta elettronica certificata o per via telematica, consentendo tempi di notifica più celeri e benefici, nel medio periodo, in termini di tempi di trattazione del procedimento.

 

Aggiornamento delle tariffe dei servizi erogati dal Ministero su richiesta

Dal 27 novembre 2021 è entrato in vigore il nuovo aggiornamento delle tariffe dovute per i servizi erogati su richiesta dalla Direzione Generale dei Dispositivi Medici e del servizio Farmaceutico (DGDMF). Questo aggiornamento è stato disposto dal Decreto Ministeriale del 6 agosto 2021, pubblicato in Gazzetta Ufficiale il 12 novembre 2021, n. 270.

Per le richieste pervenute al Ministero della salute a partire dal 27 novembre 2021, anche spedite anteriormente, per le quali sia stata pagata la precedente tariffa, occorre integrare l’importo del versamento dovuto.

Gli aggiornamenti riguardano, in particolare, i servizi relativi a:

  • biocidi (CLV)
  • cosmetici
  • dispositivi medici
  • dispositivi medico-diagnostici in vitro
  • indagini cliniche
  • PMC
  • pubblicità sanitaria
  • sostanze stupefacenti

Qui sotto il nuovo prezzario relativo a PMC e biocidi:

PRESIDI MEDICO CHIRURGICI
TIPOLOGIA DI PROCEDIMENTO IMPORTO DOVUTO
Accertamenti conseguenti alla domanda diretta ad ottenere l’autorizzazione a produrre presidi medico chirurgici Euro 3.827,60
Accertamenti conseguenti alla domanda diretta ad ottenere una modifica dell’autorizzazione a produrre presidi medico chirurgici attinente l’officina di produzione Euro 1.913,80
Accertamenti conseguenti alla domanda diretta ad ottenere una modifica dell’autorizzazione a produrre presidi medico chirurgici, non concernente l’officina di produzione e non attinente esclusivamente alla sede legale Euro 382,80
Accertamenti conseguenti alla domanda diretta ad ottenere una modifica dell’autorizzazione a produrre presidi medico chirurgici, attinente esclusivamente alla sede legale Euro 0
Accertamenti conseguenti alla domanda diretta ad ottenere l’autorizzazione a mettere in commercio un presidio medico chirurgico Euro 1.531,00
Accertamenti conseguenti alla domanda diretta ad ottenere un’integrazione o modifica dell’autorizzazione a mettere in commercio un presidio medico chirurgico, con riferimento ad ogni integrazione o modifica non imposta dal Ministero della salute attinente alla composizione o alle caratteristiche tecniche sostanziali o alla denominazione del presidio o all’officina in cui esso e’ prodotto Euro 382,80 per presidio medico chirurgico
Accertamenti conseguenti alla domanda diretta ad ottenere un’integrazione o modifica dell’autorizzazione a mettere in commercio un presidio medico chirurgico, con riferimento ad ogni modifica concernente la ragione, la denominazione sociale, la partita iva, il codice fiscale o l’indirizzo della societa’ titolare dell’autorizzazione all’immissione in commercio, anche a seguito di trasferimento della proprietà del/dei presidio/presidi medico chirurgico/i Euro 382,80 per il complesso dei presidi medico chirurgici interessati
Accertamenti conseguenti alla domanda diretta ad ottenere un’integrazione o modifica dell’autorizzazione a mettere in commercio un presidio medico chirurgico, con riferimento ad ogni modifica concernente la ragione sociale o la denominazione sociale della società che rappresenta in Italia la società estera titolare dell’autorizzazione all’immissione in commercio Euro 382,80 per il complesso dei presidi medico chirurgici interessati
Rilascio certificato di “libera vendita” Euro 95,00

 

Riferimenti: https://www.trovanorme.salute.gov.it/norme/dettaglioAtto?id=83873