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Should PVC or pthalate be banned in toys, medical & food packaging?

>PVC has been used in toys for more than 40 years. So far, there is not one known case of a child's health ever having been harmed as a result of using soft PVC toys. However, when Greenpeace started claiming that children could be harmed by the plastic toys, it caught the attention of the media and policy makers.

The European Commission has taken the position to ban six types of plasticizers (softeners). The ban doesnt apply to PVC itself, but concerns certain components may migrate or leak from PVC toys and then cause health problem.
In fact, many other material used for toys, such as rubbers, wood, PVC, contains components that can be extracted by chewing or sucking. The toxicity of any components used in the manufacture of toys must be understood before they are used and the level of exposure known before the suitability of the various materials can be assessed. All materials which are used to make toys have to be thoroughly tested and assessed before use.

PVC in toys:

For decades PVC has been a popular material for kinds of childrens products and toys made from PVC or containing PVC, include Dolls, Bath ducks, Inflatable beach toys, Paddling pools, Balls and baby care items. PVC's popularity in toys is because of its advantages on material, cost and safety.

Material advantages:
PVC is versatile. It can be used for both flexible and rigid toys with kaleidoscopic colors and can be formulated to get the exact performance and quality requirements. PVC is durable and can be used for long-lasting toys.
Costs advantages:
PVC toys can be mass-produced and allows design flexibility, factors that are very important for toy manufacturers to produce affordable toys, especially for the fast changing theme of popularity
PVC toys are safe:
PVC meets all international standards for safety and health. It has been used for more than 40 years and is the world's most researched and thoroughly tested plastic. Studies have shown that there is no health risk to children playing with PVC toys. At the end of a PVC toy's useful life, it can be recycled. Lifecycle analysis have shown that PVC is a very competitive and environmentally acceptable material..
Alternatives to PVC in toys:
Based on the study and PVC's advantages in toys, there is no substantial reasons to replace PVC. All substitutes without proven technical and safety would require additional research that usually leads to higher cost.

PVC in medical products:

In their ongoing campaign against chlorine-based chemical compounds, Greenpeace and a coalition of environmental activists called Health Care Without Harm (HCWH) is seeking to limit or prohibit the use of PVC in medical products.
There is no evidence of adverse effects from medical use of PVCs, confirmed by five to seven billion patient days of acute exposure over more than 40 years and one to two billion patient days of chronic exposure (such as patients receiving dialysis). In fact, PVC is the only flexible material approved by the European Pharmacopoeia for life-saving medical devices, and it is approved by the U.S. Food and Drug Administration (FDA).

Since there is no evidence of harm, the only reason to ban PVCs is "just to be on the safe side." But what are the trade-offs? What beneficial products will we lose? What new risks will immerge from substitutes?

In the U.S., 25 percent of all medical devices made with plastic use PVC -- including flexible tubing, intravenous bags, catheters and protective gloves.
Vinyl medical products are particularly important for blood storage, with 12 million units of blood collected in PVC blood bags each year in the U.S.
The shelf life of red blood cells is actually doubled when stored in vinyl bags.
Alternative products are more expensive, less effective or untested.

But the HCWH essentially calls for a standard that requires proving there is 'no risk' from a product before it can be used, and for withdrawing existing products whenever anyone expresses a concern, regardless of the impact on health care.

Plasticizers... What are plasticizers?

A plasticizer is a substance which when added to a material, usually a plastic, makes it flexible, resilient and easier to handle. Modern plasticizers are synthetic organic chemicals - esters, such as adipates and phthalates. More importantly, they are not just additives (like pigments or fillers). Rather they are major components that determine the physical properties of polymer products. Plasticizers are also used in rubber products, paints, printing inks, adhesives, lubricants and some cosmetics. However, the majority of plasticizers are used in the production of flexible PVC.
Plasticizers included primary plasticizers and secondary plasticizers.

Primary Plasticizers:

Usually plasticizers mainly refer to primary ones. They include:

Adipates: for low temperature applications, higher cost
Phosphates: low volatility, but mainly for fire retardant purpose because of cost concern
Phthalates: the current most common used plasticizers
Trimelliates: usually for high temperature applications such as cable and wire
Sebactaes & Azelates: limited to superior low temperature applications
Citrates: medical equipment and packaging film

Secondary Plasticizers:

Secondary plasticizers, also known as extenders, do not impart flexibility to the PVC resin alone and are combined with a primary plasticizer.

Ban of phthalates


The most commonly used plasticizers are phthalates. They are colorless, odorless liquids. Their principle use is to soften the popular plastic, polyvinyl chloride (PVC). Plasticized PVC is used in a wide range of applications such as medical tubing and bloodbags, footwear, stationery goods, flooring and wall-coverings, electrical cable insulation, clothing and toys.

The most common phthalates are di-2-ethyl hexyl phthalate (DEHP, also sometimes called DOP), diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). In toys, DINP is currently used to give raw PVC the desired qualities of flexibility.
Phthalate plasticizers are increasingly facing resistance for application in flexible PVC toys, medical products like blood bags and tubes as well as for food packaging. Phthalates are considered to be of some risk to human health. There is an increasing concern by public and regulatory agencies about any bad effect that could arise from Phthalates, even though it may not yet be scientifically proven. A study carried out showed that Asian mothers would be willing to pay more to ensure safe toys. The European Commission has introduced a ban on the rise of Phthalates in teething toys (i.e. toys for young children who are likely to chew the toys).

Some other members of ECC, like Italy, prohibit use of phthalates beyond 5% in packaging of food products while many others cautiously limited the amount of phthalates to 0.05% (500ppm) of individual or total six phthalates, DINP, DNOP, DEHP(or DOP), DIDP, BBP and DBP). EU risks assessments are expected to be available in early 2001. In USA, according to ASTM F963, pacifiers, rattles and teether that contain more than 3% DEHP should be banned. While teething toys is relatively a small market, the international toy manufacturers such as Mattel or Toys "R" US have decided to phase out phthalates across the entire range of flexible PVC toys.


As the public debate is going on, toy manufacturers are trying hard to look for alternative plasticizers to phthalates rather than give up using PVC in toys. This is because the irreplaceable benefits of PVC in toy applicant. Current most commonly used alternatives to these six phthalates are:

DINA EPZ (Edible Plasticizer)
TXIB Plasticizer (commonly called hard oil)
168 Plasticizer)

Several producers of flexible PVC products have been switching over to alternate benign plasticizers such as Citric Acid Esters or Polyesters. A major stumbling block for usage of citric acid plasticizer is its cost compared to phthalates.
Polyester introduced in Japan of slightly lower cost as compared to citrate plasticizer could provide a cost effective alternate. However both of these options increase cost of PVC toys. This may provide an opportunity to thermoplastic elastomers to emerge as strong competition to flexible PVC products.

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