natgillin/translations-raw huggingface dataset:
Structures and processes should be established to ensure that the information relevant for the update of the cosmetic product safety report is efficiently exchanged between the responsible person and the safety assessor, and that the safety assessor is in a position to intervene where an update is necessary.
Vzpostaviti je treba mehanizme in postopke za zagotovitev, da se med odgovorno osebo in ocenjevalcem varnosti učinkovito izmenjujejo informacije, ki so pomembne za posodobitev poročila o varnosti kozmetičnega izdelka, ter da lahko ocenjevalec varnosti posreduje, kadar je potrebna posodobitev.
Assessor’s credentials and approval of Part B
Dokazila o verodostojnosti ocenjevalca in odobritev dela B
The safety assessor is to be a professional with the necessary knowledge and expertise to draw up an accurate safety assessment, as indicated by the qualification requirements in Article 10(2) of Regulation (EC) No 1223/2009.
Ocenjevalec varnosti mora biti strokovnjak z ustreznim znanjem in izkušnjami za pripravo pravilne ocene varnosti, kot določajo zahteve glede usposobljenosti v členu 10(2) Uredbe (ES) št. 1223/2009.
That section of the cosmetic product safety report aims at ensuring that this requirement is met and that the necessary evidence is provided.
Namen tega oddelka poročila o varnosti kozmetičnega izdelka je zagotoviti, da so te zahteve izpolnjene in da se zagotovijo potrebna dokazila.
That section of the safety report is required to list the name and address of the safety assessor and to be dated and signed.
V tem oddelku poročila o varnosti je treba navesti ime in naslov ocenjevalca varnosti, biti mora tudi datiran in podpisan.
The result of the safety assessment is to be signed stating the date of preparation or be issued based on an electronic release establishing a clear relationship between the assessor, the formulation and the date of assessment.
Rezultat ocenjevanja varnosti mora biti podpisan, pri čemer mora biti naveden tudi datum priprave, ali izdan v elektronski različici, s katero se vzpostavlja jasna povezava med ocenjevalcem, formulacijo in datumom ocene.
The electronic version should be protected from abuse by unauthorised persons.
Elektronska različica mora biti zaščitena pred zlorabo s strani nepooblaščenih oseb.
In accordance with Article 10(2) of Regulation (EC) No 1223/2009, the safety assessor is required to be ‘a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline or a course recognised as equivalent by a Member State’.
V skladu s členom 10(2) Uredbe (ES) št. 1223/2009 mora biti ocenjevalec varnosti „oseba, ki ima diplomo ali druga dokazila o formalnih kvalifikacijah, pridobljenih ob končanju univerzitetnega teoretičnega in praktičnega študija farmacije, toksikologije, medicine ali podobne vede, ali študija, ki se v državi članici priznava kot enakovreden“.
A person who has obtained qualifications in a third country may act as a safety assessor if they have completed ‘a course recognised as equivalent [to a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline] by a Member State’.
Oseba, ki je pridobila kvalifikacije v tretji državi, lahko deluje kot ocenjevalec varnosti, če je končala „[študij], ki se v državi članici priznava kot enakovreden [univerzitetnemu teoretičnemu in praktičnemu študiju farmacije, toksikologije, medicine ali podobne vede]“.
Proof is to be provided of the safety assessor’s qualification (i.e. copy of the diploma and, where needed, proof of equivalence) laid down in Article 10 of Regulation (EC) No 1223/2009.
Zagotoviti je treba dokazilo o kvalifikacijah ocenjevalca varnosti (tj. kopijo diplome in po potrebi dokazilo o enakovrednosti), določenih v členu 10 Uredbe (ES) št. 1223/2009.
References
Viri
European Chemicals Agency (ECHA), Guidance on information requirements and chemical safety assessment — Chapter R.7a: Endpoint specific guidance, May 2008.
Evropska agencija za kemikalije (ECHA), Guidance on information requirements and chemical safety assessment – Chapter R.7a: Endpoint specific guidance, maj 2008.
European Chemicals Agency (ECHA), Guidance on information requirements and chemical safety assessment — Chapter R.7c: Endpoint specific guidance, May 2008.
Evropska agencija za kemikalije (ECHA, Guidance on information requirements and chemical safety assessment – Chapter R.7c: Endpoint specific guidance, maj 2008.
European Commission, Composition and undesirable effects of cosmetic products to be made easily accessible to the public — practical implementation of Article 7a(1)(h), second subparagraph, of Directive 76/768/EEC (http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide_access_info_en.pdf).
Evropska komisija, Composition and undesirable effects of cosmetic products to be made easily accessible to the public — practical implementation of Article 7a(1)(h), second subparagraph, of Directive 76/768/EEC (http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide_access_info_en.pdf).
Regulatory Toxicology and Pharmacology 25 (1997), p. 1-5.
Regulatory Toxicology and Pharmacology 25 (1997), str. 1–5.
Miljøstyrelsen, Guideline on Safety Assessment of Cosmetic Products, Environmental Guidelines No 10 2000.
Miljøstyrelsen, Guideline on Safety Assessment of Cosmetic Products, Environmental Guidelines, št. 10, 2000.
Series on Testing and Assessment, No 80.
Series on Testing and Assessment, št. 80.
Series on Testing and Assessment, No 102.
Series on Testing and Assessment, št. 102.
SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Opinion on the scientific basis for the definition of the term ‘nanomaterial’, 8 December 2010.
ZONNUZT (Znanstveni odbor za nastajajoča in na novo ugotovljena zdravstvena tveganja), Opinion on the scientific basis for the definition of the term „nanomaterial“, 8. december 2010.
Workshop Report ‘Assessment of undesirable events in cosmetic market surveillance: Background, description and use of a causality assessment method in cosmetovigilance’, Regulatory Toxicology and Pharmacology 58 (2010) 349–353.
Poročilo delavnice „Assessment of undesirable events in cosmetic market surveillance: Background, description and use of a causality assessment method in cosmetovigilance“, Regulatory Toxicology and Pharmacology 58 (2010) 349–353.
Article 11(2) of Regulation (EC) No 1223/2009.
Člen 11(2) Uredbe (ES) št. 1223/2009.
Article 10(1) of Regulation (EC) No 1223/2009.
Člen 10(1) Uredbe (ES) št. 1223/2009.
Article 10(1)(c) of Regulation (EC) No 1223/2009.
Člen 10(1)(c) Uredbe (ES) št. 1223/2009.
The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, SCCS/1501/12, and its subsequent updates.
Navodila Znanstvenega odbora za varstvo potrošnikov (ZOVP) za preskušanje sestavin kozmetičnih izdelkov in njihovo oceno varnosti, osma revizija, SCCS/1501/12, in njihove poznejše posodobitve (v nadaljnjem besedilu: Navodila ZOVP).
SCCS Notes of Guidance, para. 3-6.2, pp. 35-36.
Navodila ZOVP, točka 3–6.2, str. 35–36.
This point is relevant in the context of Good Manufacturing Practices, and is explicitly addressed by the relevant standard EN ISO 22716:2007.
Ta vidik je pomemben v okviru dobrih proizvodnih praks in je izrecno obravnavan v zadevnem standardu EN ISO 22716:2007.
More specifically, it matches the requirements for the release of raw materials and the finished product.
Natančneje, z njim se izpolnjujejo zahteve za sprostitev surovin in končnega izdelka v uporabo.
See section 3.3 on Microbiological quality.
Glej točko 3.3 o mikrobiološki kakovosti.
See ‘Practical implementation of Article 6(1)(c) of the Cosmetics Directive (76/768/EEC): Labelling of product durability: “period of time after opening” ’ (Council Directive 76/768/EEC, OJ L 262, 27.9.1976, p. 169) http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/wd-04-entr-cos_28_rev_version_adoptee20040419_en.pdf
Glej „Practical implementation of Article 6(1)(c) of the Cosmetics Directive“ (Direktiva Sveta 76/768/EGS, UL L 262, 27.9.1976, str. 169): „LABELLING OF PRODUCT DURABILITY: ‚PERIOD OF TIME AFTER OPENING‘ “ (http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/wd-04-entr-cos_28_rev_version_adoptee20040419_en.pdf).
SCCS Notes of Guidance, para. 4-3.3, p. 74.
Navodila ZOVP, točka 4–3.3, str. 74.
The ‘date of minimum durability’ is the date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain safe; the PAO is the period of time after opening for which the product can be used without any harm to the consumer.
„Minimalni rok trajanja“ je datum, do katerega kozmetični izdelek, shranjen pod ustreznimi pogoji, ohrani svojo prvotno funkcijo in zlasti ostane varen; PAO je časovno obdobje po odprtju, v katerem lahko uporabnik izdelek brez škode uporablja.
See ‘Practical implementation of Article 6(1)(c) of the Cosmetics Directive (76/768/EEC): Labelling of product durability: “period of time after opening” ’.
Glej „Practical implementation of Article 6(1)(c) of the Cosmetics Directive“ (Direktiva 76/768/EGS): „LABELLING OF PRODUCT DURABILITY: ‚PERIOD OF TIME AFTER OPENING‘ “.
SCCS Notes of Guidance, para 4-4, pp. 75–76.
Navodila ZOVP, točka 4–4, str. 75–76.
Article 17 of Regulation (EC) No 1223/2009 establishes that traces of prohibited substances are only permitted if they are technically unavoidable and if they have no impact on the safety of the cosmetic products.
Člen 17 Uredbe (ES) št. 1223/2009 določa, da so sledi prepovedanih snovi dovoljene samo, če so tehnično neizogibne in ne vplivajo na varnost kozmetičnih izdelkov.
The ‘non-threshold genotoxic and carcinogenic substances’ are the genotoxic and carcinogenic substances without a threshold for the carcinogenic-genotoxic effects.
„Genotoksične in rakotvorne snovi brez praga“ so genotoksične in rakotvorne snovi, ki nimajo določenega praga za genotoksične oz. rakotvorne učinke.
Opinion of the Scientific Committee on a request from EFSA related to A Harmonised Approach for Risk Assessment of Substances Which are both Genotoxic and Carcinogenic, the EFSA Journal (2005) 282, pp. 1-31.
Opinion of the Scientific Committee on a request from EFSA related to A Harmonised Approach for Risk Assessment of Substances Which are both Genotoxic and Carcinogenic, The EFSA Journal 2005; 282, str. 1–31.
To evaluate the risk, one needs to consider the hazard together with the exposure, and this is the duty of the safety assessor.
Za oceno tveganja je treba upoštevati nevarnost skupaj z izpostavljenostjo, kar je dolžnost ocenjevalca varnosti.
SCCS Notes of Guidance, para 4, p. 66 et seq.
Navodila ZOVP, točka 4, str. 66 in naslednje.
M. Pauwels, V. Rogiers, Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed Challenge to Science, Toxicology and Applied Pharmacology, 243 (2010), p. 261.
M. Pauwels in V. Rogiers, Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed Challenge to Science, Toxicology and Applied Pharmacology, 243 (2010), str. 261.
Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics, COM(2013) 135 final.
Sporočilo Komisije Evropskemu parlamentu in Svetu o prepovedi testiranja na živalih in trženja ter stanju glede alternativnih metod na področju kozmetičnih izdelkov (COM(2013) 135 final).
See in particular point 3.1 of the Communication.
Glej zlasti točko 3.1 Sporočila.
SCCS Notes of Guidance, para. 3.4.11.
Navodila ZOVP, točka 3–4.11.
Also cf. opinions SCCNFP/0068/98, an earlier version of the Notes of Guidance, and SCCNFP/0245/99 on Basic Criteria of the Protocols for the Skin Compatibility Testing of Potentially Cutaneous Irritant Cosmetic Ingredients or Mixtures of Ingredients on Human Volunteers.
Glej tudi mnenje SCCNFP/0068/98, ki je zgodnejša različica Navodil ZOVP, in mnenje SCCNFP/0245/99 z naslovom „Opinion Concerning Basic Criteria of the Protocols for the Skin Compatibility Testing of Potentially Cutaneous Irritant Cosmetic Ingredients or Mixtures of Ingredients on Human Volunteers“.
Read-across is a technique for data gap filling in which information for one or more source chemicals is used to make a prediction for a target chemical, which is considered to be similar in some way.
Navzkrižno branje je tehnika za zapolnjevanje vrzeli v podatkih, pri kateri se informacije za eno ali več začetnih kemikalij uporabijo za napovedovanje za ciljno kemikalijo, ki se po nečem šteje za podobno.
From ECHA, ‘Guidance on information requirements and chemical safety assessment Chapter R.4: Evaluation of available information’, December 2011, p. 12. http://echa.europa.eu/documents/10162/17235/information_requirements_r4_en.pdf
Glej dokument Evropske agencije za kemikalije (ECHA) z naslovom „Guidance on information requirements and chemical safety assessment – Chapter R.4: Evaluation of available information“, december 2011, str. 12 (http://echa.europa.eu/documents/10162/17235/information_requirements_r4_en.pdf).
One definition for weight of evidence is: ‘the process of considering the strengths and weaknesses of various pieces of information in reaching and supporting a conclusion concerning a property of the substance.’ From ECHA, ‘Practical guide 2: How to report weight of evidence’, 2010, p. 2, http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_en.pdf
Ena od opredelitev določanja zanesljivosti dokazov je „postopek določanja prednosti in slabosti različnih informacij pri doseganju in podpiranju sklepa o lastnosti snovi“. Glej dokument ECHA z naslovom „Praktični vodnik 2: Kako se navede določanje zanesljivosti dokazov“, 2010, str. 2 (http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_sl.pdf).
Cfr. SCCS Notes of Guidance, Section 3-6 Basic Requirements for Cosmetic Substances Present in Finished Cosmetic Products (which are to be evaluated by individual safety assessors).
Glej Navodila ZOVP, točka 3–6 z naslovom „Basic Requirements for Cosmetic Substances Present in Finished Cosmetic Products (which are to be evaluated by individual safety assessors)“.
The SCCS Notes of Guidance clearly address this issue in para. 3-6.1 General toxicological requirements.
V Navodilih ZOVP je ta vidik jasno obravnavan v točki 3–6.1 z naslovom „General toxicological requirements“.
According to the SCCS’s Notes of Guidance (para. 3-4.5), priority should be given to the NOAEL as regards sub-chronic toxicity (90 day study).
V skladu z Navodili ZOVP (točka 3–4.5) je treba prednost dati vrednostim NOAEL v zvezi s subkronično strupenostjo (90-dnevna študija).
Only if such values are not available should results relating to sub-acute toxicity (28-day study) be used.
Šele, če take vrednosti niso na voljo, je treba uporabiti rezultate v zvezi s subakutno strupenostjo (28-dnevna študija).
ECHA, Guidance on information requirements and chemical safety assessment — Chapter R.7a: Endpoint specific guidance, May 2008.
ECHA, Guidance on information requirements and chemical safety assessment – Chapter R.7a: Endpoint specific guidance, maj 2008.
Cfr. ECHA, Guidance for identification and naming of substances under REACH and CLP, November 2011, p. 29. http://echa.europa.eu/documents/10162/17235/substance_id_en.pdf
Glej ECHA, Smernice za identifikacijo in poimenovanje snovi v skladu z uredbama REACH in CLP, november 2011, str. 29 (http://echa.europa.eu/documents/10162/17235/substance_id_sl.pdf).
I.e.‘the systemically available dose that passes the relevant physical barriers (gastro-intestinal, skin or lung structures) and becomes available in the blood stream for subsequent distribution to tissues and organs’, ref. M. Pauwels, V. Rogiers, p. 262.
Tj. „sistemsko razpoložljiv odmerek, ki preide zadevne telesne pregrade (gastrointestinalne, kožne ali pljučne strukture) in postane na voljo v krvnem obtoku za poznejšo porazdelitev med tkiva in organe“. Glej zgoraj navedeni članek M. Pauwels in V. Rogiers, str. 262.
SCCS Notes of Guidance, para 3-7.2, p. 49.
Navodila ZOVP, točka 3–7.2, str. 49.
M. Pauwels, V. Rogiers, p. 262.
Zgoraj navedeni članek M. Pauwels in V. Rogiers, str. 262.
SCCS, SCHER and SCENIHR, Opinion on Use of the Threshold of Toxicological Concern (TTC) Approach for Human Safety Assessment of Chemical Substances with focus on Cosmetics and Consumer Products, SCCP/1171/08.
ZOVP, ZOZOT in ZONNUZT, Opinion on Use of the Threshold of Toxicological Concern (TTC) Approach for Human Safety Assessment of Chemical Substances with focus on Cosmetics and Consumer Products, SCCP/1171/08.
SCCS Note of Guidance, para 3-7, p. 46.
Navodila ZOVP, točka 3–7, str. 46.
The Interdepartmental Group on Health Risks from Chemicals (2006), http://www.silsoe.cranfield.ac.uk/ieh/ighrc/ighrc.html
The Interdepartmental Group on Health Risks from Chemicals (2006) (http://www.silsoe.cranfield.ac.uk/ieh/ighrc/ighrc.html).
See for example: SCCS (Scientific Committee on Consumer Safety), Guidance on safety assessment of nanomaterials in cosmetics, SCCS/1484/12; SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Opinion on the scientific basis for the definition of the term ‘nanomaterial’, 8 December 2010.
Glej na primer: ZOVP (Znanstveni odbor za varstvo potrošnikov), Guidance on safety assessment of nanomaterials in cosmetics, SCCS/1484/12; ZONNUZT (Znanstveni odbor za nastajajoča in na novo ugotovljena zdravstvena tveganja), Opinion on the scientific basis for the definition of the term „nanomaterial“, 8. december 2010.
R. Kroes, A. G. Renwick, V. Feron, C. L. Galli, M. Gibney, H. Greim, R. H. Guy, J. C. Lhuguenot, J. J. M. van de Sandt, Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients, Food and Chemical Toxicology 45 (2007), pp. 2533–2562.
R. Kroes, A. G. Renwick, V. Feron, C. L. Galli, M. Gibney, H. Greim, R. H. Guy, J. C. Lhuguenot, J. J. M. van de Sandt, Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients, Food and Chemical Toxicology 45 (2007), str. 2533–2562.
Several publicly available databases containing toxicological data on substances used in cosmetics exist, and are listed in the Appendix to this Guideline.
Obstaja več javno dostopnih zbirk podatkov, ki vsebujejo toksikološke podatke o snoveh, ki se uporabljajo v kozmetičnih izdelkih, in ki so navedene v Dodatku k tem smernicam.
OJ L 353, 31.12.2008, p. 1, and ECHA’s registration website: http://apps.echa.europa.eu/registered/registered-sub.aspx
UL L 353, 31.12.2008, str. 1, in spletna stran agencije ECHA v zvezi z registracijo: http://apps.echa.europa.eu/registered/registered-sub.aspx
This is a consequence of the requirement of Article 23 of Regulation (EC) No 1223/2009, which establishes the obligation for responsible persons to notify serious undesirable effects to competent authorities in the EU Member States.
To je posledica zahteve iz člena 23 Uredbe (ES) št. 1223/2009, ki določa, da morajo odgovorne osebe resne neželene učinke sporočati pristojnim organom v državah članicah EU.
Article 23 of Regulation (EC) No 1223/2009.
Člen 23 Uredbe (ES) št. 1223/2009.
For undesirable effects that are very likely or likely to be attributable to the cosmetic product, Article 21 of Regulation (EC) No 1223/2009, ‘Access to information for the public’, applies.
Za neželene učinke, za katere je zelo verjetno ali verjetno, da jih je mogoče pripisati kozmetičnemu izdelku, se uporablja člen 21 Uredbe (ES) št. 1223/2009, naslovljen „Dostop do informacij za javnost“.
European Commission, Serious Undesirable Effects (SUE) Reporting Guidelines, http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/sue_reporting_guidelines_en.pdf
Evropska komisija, Smernice za poročanje o resnih neželenih učinkih (http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/sue/sue_sl.pdf).
This is an obligation of the responsible person according to article 10(1)(c) of Regulation (EC) No 1223/2009.
To je obveznost odgovorne osebe v skladu s členom 10(1)(c) Uredbe (ES) št. 1223/2009.
Available on http://ec.europa.eu/consumers/sectors/cosmetics/documents/guidelines/labelling/index_en.htm
Na voljo na spletnem naslovu: http://ec.europa.eu/consumers/sectors/cosmetics/documents/guidelines/labelling/index_en.htm
Available on http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide_labelling200802_en.pdf
Na voljo na spletnem naslovu: http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide_labelling200802_en.pdf
For products in the same range, where the only difference among different products is the colouring agent, and that has no impact on safety, e.g. for lipsticks or other colour make-up, a combined product safety report may be considered, but is to be justified.
Za izdelke v istih sklopih, v katerih je edina razlika med različnimi izdelki barvilo, ki ne vpliva na varnost, npr. za ličila za ustnice ali druga ličila, se lahko pripravi združeno poročilo o varnosti izdelka, ki pa ga je treba utemeljiti.
SCCS, SCHER, SCENIHR, Toxicity and Assessment of Chemical Mixtures, 2012 http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_155.pdf
ZOVP, ZOZOT in ZONNUZT, Toxicity and Assessment of Chemical Mixtures, 2012 (http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_155.pdf).
SCCS Notes of Guidance, para 3-7.3, p. 51.
Navodila ZOVP, točka 3–7.3, str. 51.
The product information file should be updated when necessary and kept readily accessible, in electronic or other format, at the address of the responsible person given on the label, to the competent authorities for market surveillance purposes for a period of 10 years following the placing on the market of the last batch of the product.
To dokumentacijo je treba po potrebi posodabljati, poleg tega pa mora biti v elektronski ali drugi obliki na naslovu odgovorne osebe, navedenem na embalaži izdelka, vedno dostopna pristojnim organom za namene nadzora trga, in sicer še 10 let po tem, ko je bila na trg dana zadnja serija izdelka.
The most important element of the product information file, from a safety point of view, is the cosmetic product safety report referred to in Article 10(1).
Najpomembnejši del dokumentacije z informacijami o izdelku z vidika varnosti je poročilo o varnosti kozmetičnega izdelka iz člena 10(1).
ECHA, Practical guide 2: How to report weight of evidence’, 2010, http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_en.pdf
Evropska agencija za kemikalije (ECHA), Praktični vodnik 2: Kako se navede določanje zanesljivosti dokazov, 2010 (http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_sl.pdf).
Bremmer H.J., Prud’homme de Lodder L.C.H., van Engelen J.G.M., Cosmetics Fact Sheet to Assess the Risks for the Consumer, Updated version for ConsExpo 4, RIVM report 320104001/2006 (http://www.rivm.nl/bibliotheek/rapporten/320104001.pdf).
Bremmer, H. J., Prud’homme de Lodder, L. C. H., van Engelen, J. G. M., Cosmetics Fact Sheet to Assess the Risks for the Consumer, Updated version for ConsExpo 4, RIVM report 320104001/2006 (http://www.rivm.nl/bibliotheek/rapporten/320104001.pdf).
European Chemicals Agency (ECHA), Guidance for identification and naming of substances under REACH and CLP, November 2011.
Evropska agencija za kemikalije (ECHA), Smernice za identifikacijo in poimenovanje snovi v skladu z uredbama REACH in CLP, november 2011.
European Chemicals Agency (ECHA), Guidance on information requirements and chemical safety assessment Chapter R.4: Evaluation of available information, December 2011.
Evropska agencija za kemikalije (ECHA), Guidance on information requirements and chemical safety assessment – Chapter R.4: Evaluation of available information, december 2011.