CEN Guide 16:2017
(Main)Guide for addressing chemicals in standards for consumer-relevant products
Guide for addressing chemicals in standards for consumer-relevant products
This document provides guidance on addressing chemicals in the development of standards for consumer-relevant articles. The aim is to minimize the impacts of chemicals of concern on human health and the environment by complying with, complementing or going beyond legal obligations for environmental dimension is considered, where feasible and where appropriate, for instance by addressing environmental exposure or persistent or bio-accumulative chemicals.
The Guide is intended to assist in the development of normative provisions for chemicals, particularly in those areas where specific regulatory provisions (e.g. limit values) for chemicals are absent and are not envisaged to be implemented in the foreseeable future such as articles covered by the General Product Safety Directive (2001/95/EC). In so doing, the Guide aims to facilitate the placing on the market of safe products. In addition, these guidelines can assist those with a general professional interest in consumer safety.
The Guide including the associated background information document presents a comprehensive overview of approaches taken on chemicals in various legislative and voluntary tools. It is not intended to override legal obligations. Both documents reflect the status as of April 2017.
Electrical and electronic equipment, and ICT products, are excluded from the scope as these products fall under the lead of CENELEC and ETSI, respectively. Food contact materials, materials used in the supply of drinking water, medical devices, and construction products are also excluded. This is because comprehensive, detailed and specific regulation on chemicals in these products is either already available or subject to consideration and debate; because specific approaches are required; or because performance requirements are supposed to be addressed at national level; or a combination of all these. Nonetheless, some of the guidance may be useful in areas excluded from the scope of the Guide.
It is envisaged that sector specific guides or standards dealing with chemical hazards in standards for consumer-relevant articles, where available, should be used in conjunction with the present Guide.
NOTE The Bibliography includes relevant CEN sector guidance documents.
Vodilo za obravnavanje kemikalij v standardih za proizvode, ki so pomembni za porabnike
Ta dokument podaja smernice za obravnavanje kemikalij pri oblikovanju standardov za proizvode, ki so pomembni za porabnike. Namen je zmanjšati vpliv problematičnih kemikalij na človeško zdravje in okolje, tako da se upošteva ali dopolni pravne zahteve glede teh kemikalij oziroma se uvede ukrepe, ki presegajo te pravne zahteve. Poudarek je na kemikalijah v proizvodih, ki pri uporabi predstavljajo tveganje za človeško zdravje. Okoljski vidik se upošteva, kjer je to mogoče in potrebno, na primer z obravnavanjem okoljske izpostavljenosti obstojnih ali bioakumulativnih kemikalij.
Vodilo je namenjeno kot pomoč pri oblikovanju normativnih določb za kemikalije, predvsem na področjih, kjer posebne regulativne določbe (npr. mejne vrednosti) za kemikalije ne obstajajo in ne bodo oblikovane v bližnji prihodnosti, kot so določbe, zajete v Direktivi o splošni varnosti proizvodov (2001/95/ES). Vodilo tako poskuša poenostaviti dajanje varnih proizvodov na trg. Poleg tega so lahko te smernice v pomoč osebam s splošnim strokovnim interesom za varnost uporabnikov.
Vodilo, vključno s povezanim dokumentom z dodatnimi informacijami, predstavlja celovit pregled pristopov za urejanje področja kemikalij v različnih zakonodajnih in prostovoljnih orodjih. Vodilo ne
nadomešča pravnih zahtev. Dokumenta prikazujeta stanje iz aprila 2017.
Električna in elektronska oprema ter izdelki IKT ne spadajo na področje uporabe teh dokumentov, ker
jih urejata odbora CENELEC in ETSI: Materiali, ki so v stiku s hrano, materiali, ki se uporabljajo za
dobavo pitne vode, zdravstvene naprave in gradbeni izdelki ne spadajo na področje uporabe. Celoviti, podrobni in posebni predpisi glede kemikalij v teh izdelkih namreč že obstajajo ali o njih že potekajo pogovori, so zanje potrebni posebni pristopi ali morajo biti zahteve glede njihove vsebine obravnavane na nacionalni ravni oziroma zanje velja vse od naštetega.
Kljub temu so nekatere smernice lahko uporabne tudi na področjih, ki jih to vodilo ne ureja. Predvideva se, da se vodila ali standardi, povezani z določenimi področji, ki obravnavajo kemične nevarnosti v standardih za proizvode, ki so pomembni za porabnike, uporabljajo skupaj s tem vodilom.
OPOMBA: Bibliografija vključuje ustrezne dokumente CEN s smernicami za področje.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-V CEN Guide 16:2017
01-december-2017
Vodilo za obravnavanje kemikalij v standardih za proizvode, ki so pomembni za
porabnike
Guide for addressing chemicals in standards for consumer-relevant products
Ta slovenski standard je istoveten z: CEN Guide 16:2017
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
03.080.30 Storitve za potrošnike Services for consumers
71.020 Proizvodnja v kemijski Production in the chemical
industriji industry
SIST-V CEN Guide 16:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-V CEN Guide 16:2017
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SIST-V CEN Guide 16:2017
CEN
GUIDE
16
Guide for addressing chemicals in
standards for consumer-relevant
products
Edition 1, 2017-07-19
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SIST-V CEN Guide 16:2017
CEN Guide 16:2017 (E)
Contents Page
Foreword . 6
Introduction . 7
1 Scope . 7
2 Terms and definitions . 8
3 Regulatory, normative and policy background . 8
3.1 General . 8
3.2 Chemicals legislation . 9
3.2.1 REACH Regulation . 9
3.2.2 CLP Regulation . 10
3.2.3 Other relevant chemicals legislation . 11
3.3 Relevant EU regulation for articles and associated standards . 11
3.3.1 General considerations . 11
3.3.2 General Product Safety Directive (GPSD) and related standards . 12
3.3.3 Toy Safety Directive (TSD) and related standards . 12
3.4 EU policy developments, discussions, scientific opinions and tools relevant to
chemicals . 13
3.5 Relevant national product regulation and policy developments . 14
3.6 Voluntary specifications (ecolabel criteria, industry initiatives and standards) . 15
3.7 International developments . 16
4 Basics of Chemical Safety Assessment (CSA) . 16
5 Chemical requirements for consumer-relevant articles . 17
5.1 General aspects . 17
5.2 Substances of Very High Concern (SVHC) included in Annex XIV of REACH . 18
5.3 Carcinogenic, mutagenic and toxic to reproduction (CMR) substances – generic
provisions . 18
5.4 Generic provisions for other hazard classes in the CLP Regulation . 20
5.5 Generic provisions for other hazard properties not covered by the CLP Regulation . 20
5.5.1 Endocrine disrupting chemicals (EDCs) .
...
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