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►TOYS
►REGULATIONS OF DIFFERENT COUNTRIES
(I) EU Regulation
The
Pentechlorophenol (PCP) requirement
of the European Regulation (EC) No. 1907/2006 of the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH),
Annex XVII concerning the Restrictions on the manufacture, placing
on the market and use of certain dangerous substances, preparations
and articles, Item no. 22.
Limit (in general) = 0.1% (1000 ppm)
(II)
German Regulations / Test Methods
German Food and Commodities Act LMBG,
Recommendation XL VII
Chemikalienverbotsverordnung
– Chemical prohibition
Act – Pentachlorophenol
(PCP) in wood and textiles
Extractable PCP - German Chemical
Prohibition Regulation Appendix 15, DIN 53313:1996
DIN CEN/TS14494, § 35 LMBG B 82.02-8 2001-06, IUC 25 – Nachweis und Bestimmung von Pentachlorphenol in Bedarfsgegenständen, insbesondere aus Leder und Textilien (DIN 53313)
Leather and
Textiles - Chemical tests - Determination of Pentachlorophenol (PCP) content
(III)
Germany – Pentachlorophenol (PCP) in several products
Pentachlorophenol (PCP) can be used to
prevent fungal growth and decay by bacteria. In textile and leather industry,
PCP is mostly used for preservation finishing; in ligneous products PCP can be
used in conservation paints. PCP can also be used in wooden toys and
handicrafts.
PCP and its salts are highly toxic for aquatic systems, harmful to human health
and highly persistent in the environment. Products containing PCP may form
highly toxic substances when they are incinerated.
In Germany, import and trade of products containing more than 5 ppm PCP (pentachlorophenol),
pentachlorophenol sodium, all pentachlorophenol salts and compounds in products
is prohibited. In practice, the low maximum concentrations allowed in
The legislation in
(IV) Regulatory Impact Assessment -- Pentachlorophenol (PCP)
Implementation of the 5th amendment to Annex 1 of the Marketing and Use
Directive - Council Directive 76/769/EEC (Pentachlorophenol)
1. Purpose and
Intended Effect of the Measure
New Regulations to introduce a lower permissible content of total
hexachlordibenzoparadioxin (H6CDD) in pentachlorophenol (PCP)
preparations placed on the market. Required to meet the UK's obligation to
implement the provisions (in part) of European Commission Directive 1999/51/EC
(the 5th amendment to Annex 1 of the Marketing and Use Directive
76/769/EEC).
The Regulations reduce the permitted total H6CDD content in PCP,
or any substance containing PCP, to 2 parts per million from 4 parts per
million and provide that PCPs may no longer be used in industrial installations
as a synthesising and/or processing agent in industrial processes. The
Regulations also remove the exemption permitting the use of structural timbers
treated with PCPs.
Given the hazards of PCP and H6CDD, the Regulations seek to
minimise the overall risk to man and the environment.
2. Risk
Assessment
The Directive was negotiated in 1998/99 as part of a package including
organostannic compounds (tributyltin) and cadmium; DTI, HSE and the then DETR
collaborated in these discussions. The Directive was negotiated because of the
EU Accession Treaty for Sweden, Finland and Austria (who had previously banned
PCP). It is based on an assessment of human occupational and consumer exposure
as well as environmental risk conducted by Environmental Resources Management
(ERM) Ltd on behalf of the European Commission. A detailed opinion was given by
the EC Scientific Committee for Toxicity, Ecotoxicity and Environment (CSTEE),
based on the ERM report and additional published literature. The CSTEE
concluded that human exposure could occur from contaminated soil and that there
was a risk to the environment from localised 'hotspots'.
3. Options
The proposed Regulations are required to fulfil the UK's obligation to
implement the provisions (in part) of European Commission Directive 1999/51/EC
(the 5th amendment to Annex 1 of the Marketing and Use Directive 76/769/EEC).
Directive 76/769/EEC harmonises Member States' controls over the marketing and
use of dangerous substances and a series of amendments since 1976 have added
further substances and/or restrictions to those already controlled. Article 2
of the Directive calls for Member States to apply its provisions from 1
September 2000. There are no options other than to implement. Failure to do so
will result in legal action by the European Commission against the UK.
4. Benefits
The Regulations minimise risks posed by PCP and H6CDD to human
health and the environment in the EU. PCP is known to cause chloracne in
occupational exposures and is on the EU 'red list' as toxic to the environment;
H6CDD is an unwanted contaminant in PCP.
5. Business
Sectors Affected
PCP is manufactured in the United States and imported for use by the Wood
Preserving and Damp Proofing industry and the Textile industry, which are the
only UK sectors to be affected by this legislation. Most companies have already
withdrawn PCP products on commercial grounds and remaining uses are due to
cease in 2008 in any case. The UK firm Catomance Ltd produces PCP laurate as a
synthesising/processing agent, but DG Sanco have confirmed that this manufacture
is not prohibited by this Directive. The Defence Logistics Organisation (DLO),
which used PCP laurate for application to military items such as parachute
webbing, have confirmed that they have taken steps to secure alternative
finishes for the products under their responsibility.
6. Compliance
Costs for a Typical Business
No costs to business are expected as a consequence of the Regulations. We
have conducted the normal consultation process with the Wood Preserving and
Damp Proofing industry, the Textile industry, DLO and Catomance Ltd, none of
whom made any comments. DLO will incur costs in testing for an alternative
which meets NATO specifications, but it appears unlikely that these will be
passed on to business.
7. Consultation
Process
The DTI, the National Assembly of Wales and the Scottish Executive were
consulted in the normal way and all are content with implementation of the
proposed Regulations on a GB-wide basis, as proposed. DoENI are transposing the
requirements of 1999/51/EC separately into Northern Ireland legislation.
8. Summary and
Recommendations
It is recommended that the part of Directive 1999/51/EC dealing with PCP is
enacted into national law using powers conferred by section 2(2) of the
European Communities Act 1972. This option minimises risks posed by PCP and
fulfils the UK's obligation to implement the provisions of the European
Directive. The costs associated with the Regulations will be negligible.
(V)
What is Pentechlorophenol (PCP) ?
Introduction
Pentachlorophenol
(PCP) is a synthetic substance that
was first produced in the 1930s. It is marketed under the trade names,
Santophen, Pentachlorol, Chlorophen, Chlon, Dowicide 7, Pentacon, Penwar,
Sinituho and Penta among others. It can be found in two forms: PCP itself or as
the sodium salt of PCP, which dissolves easily in water. In the past, it has
been used as a herbicide, insecticide, fungicide, algaecide, disinfectant and
as an ingredient in antifouling paint. Some applications were in agricultural
seeds (for nonfood uses), leather, masonry, wood preservation, cooling tower
water, rope and paper mill system.
Since the early 1980s, the purchase and use of PCP in the U.S has not been
available to the general public. Nowadays most of the PCP used in the U.S is
restricted to the treatment of utility poles and railroads ties.
There are two general methods for preserving wood. The pressure process
method involves placing wood in a pressure-treating vessel where it is immersed
in PCP and then subjected to applied pressure. In the non-pressure process
method, PCP is applied by spraying, brushing, dipping, and soaking. Utility
companies save millions of dollars in replacement poles, because the life of
these poles increases from approximately 7 years for an untreated pole to about
35 years for a preservative-treated pole.
Toxicity
Short-term exposure to large amounts of PCP can cause harmful effects on
the liver, kidneys, blood, lungs, nervous system, immune system, and gastrointestinal tract. Further,
elevated temperature, profuse sweating, uncoordinated movement, muscle
twitching, and coma are additional side effects.
Contact with PCP (particularly in the form of vapor) can irritate the skin,
eyes, and mouth. Long-term exposure to low levels such as those that occur in
the workplace can cause damage to the liver, kidneys, blood, and nervous
system. Finally exposure to PCP is also associated with carcinogenic, renal,
and neurological effects. The EPA classifies PCP in group B2 (probable human
carcinogen).
Releases to the
environment
PCP has been detected in surface waters and sediments, rainwater, drinking
water, aquatic organisms, soil, and food, as well as in human milk, adipose
tissue, and urine. As PCP is generally used for its properties as a
biocidal agent, there is considerable concern about adverse ecosystem effects
in areas of PCP contamination.
Releases to the environment are decreasing as a result of falling
consumption and changing use methods. However, PCP is still released, to
surface waters from the atmosphere by wet deposition, from soil by run off and
leaching, manufacturing and processes facilities. Also, PCP is released
directly into the atmosphere via volatilization from treated wood products and
during production. Finally, releases to the soil can be by leaching from
treated wood products, atmospheric deposition in precipitation (such as rain
and snow), spills at industrial facilities and at hazardous waste sites. In the
United States, any drinking water supply with a PCP concentration exceeding the
MCL, 1 ppb,
must be notified by the water supplier to the public. Disposal of PCP and PCP
contaminated substances are regulated under RCRA as a F-listed
hazardous waste.
Environmental
fate
After PCP is released into the atmosphere it is transformed via photolysis.
The main biodegradative pathway for PCP is reductive dehalogenation. In this
process, the compound PCP is broken down to tetra-, tri-, and dichlorophenols.
Another pathway is methylation to pentaclhloroanisole (a more lipid soluble
compound). These two methods eventually lead to ring cleavage and complete
degradation.
In shallow waters, PCP is also quickly removed by photolysis. In deep or
turbid water processes such as sorption and biodegradation take place. In
reductive soil and sediments, PCP can be degraded within 14 days to 5 years,
depending on the anaerobic soil bacteria that are present. However, adsorption
of PCP in soils is pH dependent because it increases under acidic conditions
and it decreases in neutral and basic conditions.
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