Normativa

AmbitoApplicativo AmbitoApplicativoSub Normativa Link
Biomedicale Dispositivi medici Biological evaluation of medical devices (INTERNATIONAL STANDARD ISO 10993-5) http://www.iso.org/iso/catalogue_detail.htm%3Fcsnumber=36406
Biomedicale Dispositivi medici Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices (Scientific Committee on Emerging and Newly Identified Health Risks -SCENIHR 6 January 2015)
Chimico Biocidi Regolamento (UE) n.  528/2012 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32012R0528
Chimico Cosmetici Council of Europe. Resolution ResAP(2008)1 on requirements and criteria for the safety of tattoos and permanent make-up (superseding resolution ResAP(2003)2 on tattoos and permanent make-up). Strasbourg, France: Council of Europe; 2008.
Chimico Cosmetici European Commission. Engineered Nanoparticles: Review of Health and Environmental Safety. Seventh Framework Programme, 2009. http://ec.europa.eu/research/environment/pdf/fp7_catalogue_eh.pdf
Chimico Cosmetici European Commission. Opinion of The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers concerning the Safety of Tattoos adopted by the SCCNFP during the 11th Plenary meeting of 17 February 2000. http://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/sccnfp_opinions_97_04/sccp_out108_en.htm
Chimico Cosmetici Regolamento (CE) n.  1223/2009 Prodotti cosmetici http://eur-lex.europa.eu/legal-content/it/ALL/?uri=CELEX%3A32009R1223
Chimico Cosmetici REGOLAMENTO (UE) 2016/621 DELLA COMMISSIONE del 21 aprile 2016 che modifica l’allegato VI del regolamento (CE) n. 1223/2009 del Parlamento europeo e del Consiglio sui prodotti cosmetici
Chimico Cosmetici Scientific Committee on Consumer Products (SCCP) OPINION ON SAFETY OF NANOMATERIALS IN COSMETIC PRODUCTS Adopted by the SCCP after the public consultation on the 14th plenary of 18 December 2007 http://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_123.pdf
Chimico Cosmetici Scientific Committee on Consumer Products SCCP. Opinion on Safety of nanomaterials in cosmetic products. Adopted by the SCCP after the public consultation 14th plenary of 18 December 2007 SCCP/1147/07
Chimico Cosmetici Scientific Committee on Consumer Safety (SCCS): ‘Opinion on carbon black (nano form) SCCS/1515/13Revision of 15 December 2015
Chimico Cosmetici Scientific Committee on Consumer Safety (SCCS): ‘Opinion on titanium dioxide (nano form) COLIPA n° S75 SCCS/1516/13Revision of 22 April 2014
Chimico Cosmetici Scientific Committee on Consumer Safety (SCCS): ‘Opinion on zinc oxide (nano form) COLIPA n° S76 SCCS/1489/12Revision of 11 December 2012
Chimico Cosmetici Scientific Committee on Consumer Safety (SCCS): ADDENDUM to the OPINION SCCS/1489/12 on Zinc oxide (nano form)COLIPA S76 SCCS/1518/13 Revision of 22 Aprile 2014
Chimico Sostanze chimiche COMMISSION RECOMMENDATION of 18 October 2011 on the definition of nanomaterial (Text with EEA relevance) (2011/696/EU) http://ec.europa.eu/research/industrial_technologies/pdf/policy/commission-recommendation-on-the-definition-of-nanomater-18102011_en.pdf
Chimico Sostanze chimiche COMMISSION STAFF WORKING PAPER Types and uses of nanomaterials, including safety aspects Accompanying the Communication from the Commission to the European Parliament, the Council and the http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52012SC0288&from=EN
Chimico Sostanze chimiche COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Second Regulatory Review on Nanomaterials Brussels, 3.10.2012 COM(2012) 572 final http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52012DC0572&from=EN
Chimico Sostanze chimiche Human health and environmental exposure assessment and risk characterisation of nanomaterials Best practice for REACH registrants Third GAARN meeting Helsinki, 30 September 2013 https://echa.europa.eu/documents/10162/5399565/best_practices_human_health_environment_nano_3rd_en.pdf
Chimico Sostanze chimiche Regolamento (CE) n. 1907/2006 (REACH) http://eur-lex.europa.eu/legal-content/IT/ALL/?uri=uriserv%3Al21282
Chimico Sostanze e miscele Regolamento (CE) n. 1272/2008 (CLP) http://eur-lex.europa.eu/legal-content/IT/TXT/?uri=URISERV%3Aev0013
Farmaceutico CE: Commission Directive 2003/94/EEC of 8 October 2003 http://ec.europa.eu/health/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf
Farmaceutico CE: Commission Directive 91/356/EEC of 13 June 1991 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31991L0356&from=IT
Farmaceutico CE: DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
Farmaceutico CE: EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
Farmaceutico CE: Registro farmaci Orfani EC http://ec.europa.eu/health/documents/community-register/html/orphreg.htm
Farmaceutico CE: REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL http://ec.europa.eu/health/files/eudralex/vol-1/reg_2004_726/reg_2004_726_en.pdf
Farmaceutico CE: REGULATION (EEC) No 2309/93 Council Regulation (EEC) No 2309/93 http://ec.europa.eu/health/files/eudralex/vol-1/reg_1993_2309/reg_1993_2309_bg.pdf
Farmaceutico IT: DECRETO LEGISLATIVO 24 aprile 2006, n. 219. Attuazione della direttiva 2001/83/CE (e successive direttive di modifica) nonché della direttiva 2003/94/CE. e s.m.i. http://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2006-06-21&atto.codiceRedazionale=006G0237

 

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