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Phthalates
Phthalates Directive
REACH Annex XVII (Formerly known as 2005/84/EC)
What are Phthalates?
Phthalates have been commonly used as plasticisers to soften plastic materials such as PVC (polyvinyl chloride). Such materials have been used to make a wide range of products including toys, floor tiles, shower curtains, handbags and clothing.
Why are They Restricted?
When a child chews or sucks a plastic item for long periods of time, such as when they are using a teether, it has been shown that the plasticisers can leach out and be ingested. In 1999, the EU introduced a temporary rolling ban on six specific phthalates, which were identified as being reprotoxic. This ban was replaced by the publication of a Directive, 2005/84/EC.
Which Phthalates are Banned?
DEHP, DBP and BBP are banned for use in plasticised materials in all toys and childcare articles. (Levels must not exceed 0.1% by mass of the plasticised material)
DINP, DIDP and DNOP are banned for use in plasticised materials for those toys and childcare articles that can be placed in the mouth by children. (Levels must not exceed 0.1% by mass of the plasticised material)
EU Guidance
The EU Directive defines a childcare article as a product "intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children."
This includes items such as soothers, changing mats, highchairs, bibs and feeding bottles.
It does not include pyjamas, as they merely dress the child whilst sleeping and are not considered to "facilitate sleep".
T-shirts and other children's garments with plasticised parts such as plastic placement prints are also not defined as childcare articles.
The EU have issued a Guidance Document to address what is meant by "placed in the mouth" - it means items that can be kept in the mouth so that they can be sucked and chewed. It does not include items that can be licked.
What Products should I be Testing?
The Directive does not take into account the fact that young children instinctively place all sorts of objects in their mouth, not just toys and childcare articles. As such, there is a great deal of uncertainty in the retail market about checking products for phthalate compliance.
Many retailers have taken the view that certain clothing and accessories items would be instinctively mouthed by young children and so have implemented their own store group policy to make sure that items such as plasticised prints on clothing are compliant with the phthalates Directive.
Note:
Denmark - Danish national legislation restricts all phthalates, not just those covered by EU Directive, to a maximum of 0.05% (0.1% in EU Directive).
What is the CAS # of phthalates?
Here are some CAS # for reference. Name of Phthalates / CAS. No.
Di-Iso-nonylphthalate (DINP) 28553-12-0
Di-isobutyl phthalate (DIBP) 84-69-5
Di-n-octylphthalate (DNOP) 117-84-0
1,2-Benzenedicarboxylicacid (DHNUP) 68515-42-4
Di(2-ethylhexyl)-phthalate (DEHP) 117-81-7
1,2-Benzenedicarboxylicacid (DIHP) 71888-89-6
Diisodecylphthalate (DIDP) 26761-40-0
Bis(2-methoxyethyl) phthalate (BMEP) 117-82-8
Butylbenzylphthalate (BBP) 85-68-7
Di-n-hexyl phthalate (DHP) 84-75-3
Dibutylphthalate (DBP) 84-74-2
何谓 Phthalate ester（邻苯二甲酸酯类），一般应用为何？
邻苯二甲酸酯类是指邻苯二甲酸(Phthalate acid) 的酯化衍生物，是塑料工业中最为常见的塑化剂。所谓的塑化剂是指：在塑料原料加工时，添加塑化剂可以改变塑料成形时的物理性质，使其物理性质变为较为柔软，易于加工。而塑料，这个与我们日常生活息息相关的人造物质，藉由添加邻苯二甲酸酯可塑剂，而具有良好的延展性与稳定的物理化学特性，因此被大量使用于建筑原料、家具设备、运输工具之材料、衣物、食品包装与医药产品等。邻苯二甲酸也广泛使用于指甲油及其它化妆品、染料、PVC 地板、人工皮革及一些黏着剂。在日常及工业上被广泛添加于高分子塑料产品的生产，如聚氯乙烯(PVC)、聚丙烯(PP)、泡棉，亦可添加于胶合剂、涂料、油墨中。此外应用于地毯衬垫、驱虫剂、头发喷雾剂、指甲油等。塑化剂，主要为塑料添加剂，用来分散、软化塑料材料，像常见的聚氯乙烯PVC 因材质硬且脆，不易加工导致用途受限，因而常会添加塑化剂，使其变得柔软，甚至可当作保鲜膜使用，这就是塑化剂的”神奇”。但其造成的危害也是无法想象，国际癌症研究中心研究证实，部分的塑化剂为致癌物质，且塑化剂也被归类为环境贺尔蒙的一种，会造成人类内分泌失调，阻害生物体生殖机能，尤其对未成年的儿童来言，可能引起性早熟或性征异常的现象。2011 年台湾爆发食品添加剂使用工业用的塑化剂事件，塑化剂的危害才引起社会大众的注意。目前塑化剂于纺织工业的用途主要在塑料材质的配件，另外也常出现在塑料雨衣、人造皮革、颜料印花及涂层上。
塑料中最常添加的邻苯二甲酸酯类有下列六种：
DINP
DNOP
DIDP
DEHP
DBP
BBP
Di-isononyl Phthalate
Di-n-octyl Phthalate
Di-isodecyl Phthalate
Di-(2-ethylhexyl) Phthalate
Dibutyl Phthalate
Benzyl butyl phthalate
邻苯二甲酸二异壬酯
邻苯二甲酸二正辛酯
邻苯二甲酸二异癸酯
邻苯二甲酸二(2-乙基己基)酯
邻苯二甲酸二丁酯
邻苯二甲酸甲苯基丁酯
Phthalates对身体的危害
根据国外研究，邻苯二甲酸酯类物质除于生产过程、使用或添加在聚氯乙烯（PVC）时会释放到环境外，亦可经由垃圾掩埋场内废弃的塑料中释出，并藉由吸附于底泥或有机腐植质而散布至环境，可经由食物、空气吸入等途径进入人体。由于「邻苯二甲酸酯」为一环境荷尔蒙，属于会干扰生物体内分泌的化学物质。环境荷尔蒙进入体内后会造成内分泌失调，阻害生物体生殖机能，引发恶性肿瘤，容易造成畸形儿。目前已证明，长期处在具邻苯二甲酸酯类的环境中，可能引发气喘现象、罹患毒性多角神经炎；进入体内后虽然九成随尿液或排泄物排泄出体外，但仍有部分经过生物分解，从肝脏、肠、胃和肾脏吸收进入体内，还是对身体具相当的危害性。
Phthalates法规规范
由于人类对于邻苯二甲酸酯类的庞大需求量，使得各国在工业上大量制造并对整个生态环境造成不小的污染。目前包括欧盟及美日各国均已将此类化合物订为优先列管物质，订立相关法规管控（例如：加州AB 1108法案、REACH附录17与台湾标准检验局CNS 4797）。我国环保署，已将DEHP、DBP、DMP列管为第一类毒性化学物质管制。DnOP则被列管为第一类毒性化学物质，限制其使用用途。
各国限制法规：
- 欧盟 / REACH 之限制物 / 质（附录17）儿童玩具与婴 / 幼儿养育产品 DEHP,BBP,DBP,DNOP,DINP,DIDP / 1000ppm
- 美国 / 消费者产品安全改进法案CPSIA / 儿童玩具与婴幼儿养育产品 / DEHP,BBP,DBP,DNOP,DINP,DIDP / 1000ppm
- 丹麦 / Denmark Statutory Order 786 / 0~3 岁的婴幼儿产品 / 所有的塑化剂 / 500ppm
- 台湾 / CNS 15503 儿童用品安全一般要求 / 各类儿童用品 / DEHP,BBP,DBP,DNOP,DINP,DIDP,DMP,DEP / 1000ppm
实验简述：
利用溶剂将送测样品中的塑化剂萃取出来，再将萃取液稀释到适当的浓度，放入化学分析仪器将各化学组成分离，并由化学图谱判定结构，最后再经公式换算样品中的真实浓度。
报告结果：
报告上将显示送测样品浓度，单位为ppm 或mg/kg(相当于百万分之一)。
REACH Annex XVII (Formerly known as 2005/84/EC)
What are Phthalates?
Phthalates have been commonly used as plasticisers to soften plastic materials such as PVC (polyvinyl chloride). Such materials have been used to make a wide range of products including toys, floor tiles, shower curtains, handbags and clothing.
Why are They Restricted?
When a child chews or sucks a plastic item for long periods of time, such as when they are using a teether, it has been shown that the plasticisers can leach out and be ingested. In 1999, the EU introduced a temporary rolling ban on six specific phthalates, which were identified as being reprotoxic. This ban was replaced by the publication of a Directive, 2005/84/EC.
Which Phthalates are Banned?
DEHP, DBP and BBP are banned for use in plasticised materials in all toys and childcare articles. (Levels must not exceed 0.1% by mass of the plasticised material)
DINP, DIDP and DNOP are banned for use in plasticised materials for those toys and childcare articles that can be placed in the mouth by children. (Levels must not exceed 0.1% by mass of the plasticised material)
EU Guidance
The EU Directive defines a childcare article as a product "intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children."
This includes items such as soothers, changing mats, highchairs, bibs and feeding bottles.
It does not include pyjamas, as they merely dress the child whilst sleeping and are not considered to "facilitate sleep".
T-shirts and other children's garments with plasticised parts such as plastic placement prints are also not defined as childcare articles.
The EU have issued a Guidance Document to address what is meant by "placed in the mouth" - it means items that can be kept in the mouth so that they can be sucked and chewed. It does not include items that can be licked.
What Products should I be Testing?
The Directive does not take into account the fact that young children instinctively place all sorts of objects in their mouth, not just toys and childcare articles. As such, there is a great deal of uncertainty in the retail market about checking products for phthalate compliance.
Many retailers have taken the view that certain clothing and accessories items would be instinctively mouthed by young children and so have implemented their own store group policy to make sure that items such as plasticised prints on clothing are compliant with the phthalates Directive.
Note:
Denmark - Danish national legislation restricts all phthalates, not just those covered by EU Directive, to a maximum of 0.05% (0.1% in EU Directive).
What is the CAS # of phthalates?
Here are some CAS # for reference. Name of Phthalates / CAS. No.
Di-Iso-nonylphthalate (DINP) 28553-12-0
Di-isobutyl phthalate (DIBP) 84-69-5
Di-n-octylphthalate (DNOP) 117-84-0
1,2-Benzenedicarboxylicacid (DHNUP) 68515-42-4
Di(2-ethylhexyl)-phthalate (DEHP) 117-81-7
1,2-Benzenedicarboxylicacid (DIHP) 71888-89-6
Diisodecylphthalate (DIDP) 26761-40-0
Bis(2-methoxyethyl) phthalate (BMEP) 117-82-8
Butylbenzylphthalate (BBP) 85-68-7
Di-n-hexyl phthalate (DHP) 84-75-3
Dibutylphthalate (DBP) 84-74-2
何谓 Phthalate ester（邻苯二甲酸酯类），一般应用为何？
邻苯二甲酸酯类是指邻苯二甲酸(Phthalate acid) 的酯化衍生物，是塑料工业中最为常见的塑化剂。所谓的塑化剂是指：在塑料原料加工时，添加塑化剂可以改变塑料成形时的物理性质，使其物理性质变为较为柔软，易于加工。而塑料，这个与我们日常生活息息相关的人造物质，藉由添加邻苯二甲酸酯可塑剂，而具有良好的延展性与稳定的物理化学特性，因此被大量使用于建筑原料、家具设备、运输工具之材料、衣物、食品包装与医药产品等。邻苯二甲酸也广泛使用于指甲油及其它化妆品、染料、PVC 地板、人工皮革及一些黏着剂。在日常及工业上被广泛添加于高分子塑料产品的生产，如聚氯乙烯(PVC)、聚丙烯(PP)、泡棉，亦可添加于胶合剂、涂料、油墨中。此外应用于地毯衬垫、驱虫剂、头发喷雾剂、指甲油等。塑化剂，主要为塑料添加剂，用来分散、软化塑料材料，像常见的聚氯乙烯PVC 因材质硬且脆，不易加工导致用途受限，因而常会添加塑化剂，使其变得柔软，甚至可当作保鲜膜使用，这就是塑化剂的”神奇”。但其造成的危害也是无法想象，国际癌症研究中心研究证实，部分的塑化剂为致癌物质，且塑化剂也被归类为环境贺尔蒙的一种，会造成人类内分泌失调，阻害生物体生殖机能，尤其对未成年的儿童来言，可能引起性早熟或性征异常的现象。2011 年台湾爆发食品添加剂使用工业用的塑化剂事件，塑化剂的危害才引起社会大众的注意。目前塑化剂于纺织工业的用途主要在塑料材质的配件，另外也常出现在塑料雨衣、人造皮革、颜料印花及涂层上。
塑料中最常添加的邻苯二甲酸酯类有下列六种：
DINP
DNOP
DIDP
DEHP
DBP
BBP
Di-isononyl Phthalate
Di-n-octyl Phthalate
Di-isodecyl Phthalate
Di-(2-ethylhexyl) Phthalate
Dibutyl Phthalate
Benzyl butyl phthalate
邻苯二甲酸二异壬酯
邻苯二甲酸二正辛酯
邻苯二甲酸二异癸酯
邻苯二甲酸二(2-乙基己基)酯
邻苯二甲酸二丁酯
邻苯二甲酸甲苯基丁酯
Phthalates对身体的危害
根据国外研究，邻苯二甲酸酯类物质除于生产过程、使用或添加在聚氯乙烯（PVC）时会释放到环境外，亦可经由垃圾掩埋场内废弃的塑料中释出，并藉由吸附于底泥或有机腐植质而散布至环境，可经由食物、空气吸入等途径进入人体。由于「邻苯二甲酸酯」为一环境荷尔蒙，属于会干扰生物体内分泌的化学物质。环境荷尔蒙进入体内后会造成内分泌失调，阻害生物体生殖机能，引发恶性肿瘤，容易造成畸形儿。目前已证明，长期处在具邻苯二甲酸酯类的环境中，可能引发气喘现象、罹患毒性多角神经炎；进入体内后虽然九成随尿液或排泄物排泄出体外，但仍有部分经过生物分解，从肝脏、肠、胃和肾脏吸收进入体内，还是对身体具相当的危害性。
Phthalates法规规范
由于人类对于邻苯二甲酸酯类的庞大需求量，使得各国在工业上大量制造并对整个生态环境造成不小的污染。目前包括欧盟及美日各国均已将此类化合物订为优先列管物质，订立相关法规管控（例如：加州AB 1108法案、REACH附录17与台湾标准检验局CNS 4797）。我国环保署，已将DEHP、DBP、DMP列管为第一类毒性化学物质管制。DnOP则被列管为第一类毒性化学物质，限制其使用用途。
各国限制法规：
- 欧盟 / REACH 之限制物 / 质（附录17）儿童玩具与婴 / 幼儿养育产品 DEHP,BBP,DBP,DNOP,DINP,DIDP / 1000ppm
- 美国 / 消费者产品安全改进法案CPSIA / 儿童玩具与婴幼儿养育产品 / DEHP,BBP,DBP,DNOP,DINP,DIDP / 1000ppm
- 丹麦 / Denmark Statutory Order 786 / 0~3 岁的婴幼儿产品 / 所有的塑化剂 / 500ppm
- 台湾 / CNS 15503 儿童用品安全一般要求 / 各类儿童用品 / DEHP,BBP,DBP,DNOP,DINP,DIDP,DMP,DEP / 1000ppm
实验简述：
利用溶剂将送测样品中的塑化剂萃取出来，再将萃取液稀释到适当的浓度，放入化学分析仪器将各化学组成分离，并由化学图谱判定结构，最后再经公式换算样品中的真实浓度。
报告结果：
报告上将显示送测样品浓度，单位为ppm 或mg/kg(相当于百万分之一)。
