Swedish Statute Book
SFS
1. ------IND- 2005 0649 S-- EN- ------20051208 ------PROJET
Swedish Statute Book
SFS
Published
on
1
SFS
Order
amending the Order (1998:994) on bans etc. in certain cases in connection with the handling, import and export of chemical products
issued on xx 2006.
Having regard to the Order (1998:994) on bans etc. in certain cases in connection with the handling, import and export of chemical products, the government lays down[1] the following:
- Section 1 shall be worded as follows;
- three new Sections, Sections 4a - c, shall be inserted into the Order, and immediately before Section 4a a new heading shall be inserted worded as set out below.
Section 1[2]This Order shall apply alongside the Order (1998:941) on chemical products and biotechnical organisms with regard to
1. cadmium compounds,
2. decabromodiphenyl ether,
3. chlorinated solvents,
4. mercury,
5. cadmium, mercury, lead, hexavalent chromium and other chemical products contained in electrical and electronic products,
6. heavy metals in packaging,
7. ammunition containing lead, and
8. certain other chemical products and goods that are harmful to health or the environment.
The Order shall not apply to the chemical products and biotechnical organisms that are covered by the Foodstuffs Act (1971:511), the Medicinal Products Act (1992:859) or the Act (1985:295) on feedingstuffs.
Decabromodiphenyl ether
Section 4aDecabromodiphenyl ether (CAS number 1163-19-5) must not be placed onto the market or used as a substance or be contained in a substance or preparation at levels higher than 0.1% by weight.
Goods, or flame-protected parts thereof, containing decabromodiphenyl ether at levels higher than 0.1% by weight must not be placed on the market.
Section 4bThe prohibition in Section 4 a shall not apply to
1. vehicles as referred to in the Act (2001:559) on road traffic definitions;
2. products covered by Section 11 a.
Section 4cUnder special circumstances the Swedish Chemicals Inspectorate may issue administrative provisions on exemption from the ban in accordance with Section 4 a.
In exceptional circumstances, the Swedish Chemicals Inspectorate may grant dispensation in individual cases from the ban in Section 4 a up to 31 December 2009.
Memorandum / Annex 308.11.2005
Ministry of Sustainable Development
Impact assessment for a national ban on decabromodiphenyl ether
Introduction
This impact assessment has been performed in the light of the fact that a national ban should include use and placing on the market of decabromodiphenyl ether (decaBDE) both as a substance and contained in products or parts of products.
Use of decaBDE within the EU
According to information in a revised EU risk assessment, which followed the environmental and health risk assessment of decaBDE published in 2002 by the United Kingdom (Risk-Assessment Report Vol.17, 2002, on decabromodiphenyl ether), the world-wide production of decaBDE in 2001 was 56100 tonnes. However, no decaBDE is produced in the EU today. It is produced primarily in Japan and the USA. In the revised EU risk assessment it was estimated that during 2003 around 1300 tonnes of decaBDE was imported into the EU in products, mainly electrical and electronic products such as television sets.
The European Brominated Flame Retardant Industry Panel (EBFRIP) estimates the quantity of decaBDE used in 2003 within the EU for the manufacture of products or parts thereof to be 7300 tonnes. The majority is used to provide flame protection to plastics and other polymers used within the electronics industry (80%). The remaining 20% (1460 tonnes) is used mainly in textiles, furniture upholstery, cables, protective clothing and various bed products. Of this 20%, half (730 tonnes) is used in the United Kingdom. How use of the remaining 730 tonnes is distributed between the various EU Member States or exported in products manufactured within the EU has not been reported. DecaBDE is no longer used in Sweden. However, the import of products results in the import of a certain amount of decaBDE. The undertakings and trade organisations in Sweden which import products from other EU countries have not been able to provide information to enable the possible proportion of the 730 tonnes that might be imported into Sweden in products to be quantified.
The effect of a national ban
The draft does not cover the use of decaBDE in electrical and electronic products. Use is regulated by Directive 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic products (RoHS Directive). Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers does not allow the possibility of prohibiting type-approved vehicles containing decaBDE by means of national legislation. Therefore, vehicles are not covered by the draft Order either.
As regards the remaining areas of application, a national ban may reduce any new supplies and prevent decaBDE being used in new areas of application, thus helping to prevent increases in exposure in the future.
Compliance and control are more difficult with regard to imported products, as there is no system for providing information on chemicals contained in products. The fact that the supervisory authority does not have a clear picture of which, and how many, undertakings may be affected by a ban hampers effective supervision.
The supervisory authority may lay down requirements for reporting the substances contained in a product and issue an order, possibly associated with a fine. The supplier will then have a certain period of time to produce the desired information. Where the Swedish importer does not receive information from his foreign supplier it may lead to the importer choosing to cease selling the product or opting for a different supplier who is able to declare the content of the product. The importer may also choose to perform his own analyses on the product.
It is uncertain to what extent decaBDE is imported into Sweden in products from another EU country. Theoretically, decaBDE could be found as a component or part of a product used in a context with a very high requirement for fire protection. Such an example, which has been noted with regard to the common EU ban on pentaBDE, is the use of pentaBDE in emergency equipment in aircraft. Conversion to alternatives to pentaBDE for this application, e.g. decaBDE, takes time to implement on account of extensive test requirements. Therefore, in order to safeguard deliveries of new aircraft and spare parts for old aircraft Sweden is not introducing an absolute national ban on decaBDE. The opportunity is provided to lay down general exemptions or grant dispensation in individual cases. This provides adequate opportunity to permit the use of decaBDE within areas in which it would prove difficult to replace the substance for Swedish requirements.
Benefits to the environment and human health
DecaBDE is considered to be very persistent. There are even indications that decaBDE causes damage during brain development as well as suspicions that decaBDE may bioaccumulate. DecaBDE has also been shown to be capable of degrading to lower brominated and probably more toxic diphenyl ethers. There is insufficient information at present to classify decaBDE as a PBT substance (Persistent, Bioaccumulative and Toxic), but further studies relating to this issue are planned at EU level. On the basis of the precautionary principle and of the available studies of the substances it is justified to prevent further release of decaBDE to the environment.
A national ban may have a positive effect with regard to the possibility of achieving objective 3 of Sweden’s national environmental objectives, Giftfri miljö [A non-toxin environment], and provide an increased level of protection for consumers as regards the supply of new quantities of decaBDE. Since it is not possible to quantify the extent to which decaBDE enters Sweden via imported products it is also not possible to identify a particular area of application where a phase-out would have the most positive effects on health and the environment. It can therefore be considered justified to produce general provisions.
The quantity of decaBDE that has already accumulated in the environment or which escapes from the products already in use will not be limited by a ban.
The assessment of benefits to the environment and human health applies provided that alternatives to decaBDE do not comprise other substances with properties that are similar to or more dangerous than decaBDE, such as hexabromocyclododecane (HBCD). The Swedish Chemicals Inspectorate’s inspection project “Flamskydd i varor 2003”[Flame protection in products 2003] indicates however that the flame retardants used most are organic phosphorous and nitrogen compounds as well as inorganic salts such as aluminium and magnesium salts.
Alternatives to decaBDE as a flame retardant
Alternative flame retardants already exist in the applications that should be affected by a national ban on decaBDE. The fire protection standards in existence do not specify a particular type of flame retardant or technique for complying with the requirements laid down. It is therefore entirely possibly to meet the requirements for fire protection using alternatives to decaBDE.
Current alternatives to decaBDE used in textile applications are mostly inorganic phosphorous and nitrogen compounds as well as halogenated compounds. Intumescent (expansive) systems based on the formation of expanded coal tar are also used to a certain extent. The coal tar acts both as an insulating barrier to heat and as a waste gas trap. The intumescent systems are still in the developmental stages but increased use of these is predicted for the future, the same being the case for the use of flame-resistant fibres. For construction products made of wood fibres and recycled paper, borax or boric acid are normally used. For pipes made of various plastics, pressed graphite is used, for example. Plastic and rubber polymers for cables can be flame-protected using magnesium or aluminium hydroxide and antimony trioxide, among others.
A national ban will not therefore affect the possibility of meeting the fire protection requirements in force.
Economic and competitive conditions
In order to be neutral as regards competition, a national ban should not only cover the use of the substance decaBDE, but also products containing decaBDE imported from another EU Member State or a non-EU country.
A national ban could prevent products entering the country if the foreign supplier cannot or will not state whether decaBDE is contained in the product. A Swedish supplier who does not receive this information can choose another supplier or cease to sell the product. In connection with supervision by the authorities, the supplier may have to pay for an analysis of the product. Such an analysis, carried out using gas chromatography, costs SEK 3000 – 5000, provided that the polymer that the product is made of is known. Where it is not known, the cost may rise to SEK 20000 in order to develop a new method. The costs of analyses rest primarily with the first link in the chain, i.e. the party importing the product into Sweden. In this respect, smaller companies in particular, which do not have the same ability as large companies to influence foreign suppliers, could be faced with higher costs.
In the event of a ban, the subsequent links in the product chain will require information from the party importing a product from another EU Member State. Thus, there may be a shift in the market, with the domestic undertakings that are able to supply a product which they can show with certainty does not contain decaBDE taking over a large share of the market. The overall market for such products will therefore be the same, but the market structure may change.
The most common scenario is for a customer to require a product to comply with flame retardancy requirements in accordance with a particular standard. Where the supplier can produce a certificate to show that the product complies with the requirement, the customer is generally satisfied. However, if a foreign customer expressly wishes to have a product flame-protected using decaBDE there is a risk of loss of income. Such a product group could be upholstered furniture, for which British test institutes recommend the use of decaBDE as a flame retardant. The United Kingdom is the largest user of decaBDE within the EU. However, exports to the United Kingdom are very limited and sporadic. Only 2% of the production value for upholstered furniture relates to exports to the United Kingdom. A large decrease in orders is not therefore anticipated.
Neither is there a risk of Swedish manufacturers moving production to another country, as Swedish manufacturers no longer use decaBDE. The costs arising as a result of the conversion to other flame retardants or techniques were in most cases incurred by undertakings several years ago. The initial increase in costs was calculated to be in the region of 15-30% and has already been written off. There is currently no price difference. However, a foreign supplier may incur increased costs for product development and verification, which may lead to a higher price for the product for Swedish suppliers.
Summary
The ban does not include electrical and electronic products or vehicles. DecaBDE is neither produced nor used in Sweden. A national ban will therefore have no effect at all on Sweden’s trade with other countries within the EU as regards the substance decaBDE.
Imports of products from other EU Member States or non-EU countries means that a certain amount of decaBDE is brought in. However, it is not possible to fully quantify the benefits of a national ban to human health and the environment, as there is no system within the EU or Sweden for providing information on the substances contained in products. If the importer cannot obtain information from the supplier as to whether or not decaBDE is contained in the product, the importer can opt to change supplier or have the product analysed. The Swedish importer could also choose to influence the supplier to change agent or technique. A national ban may therefore be important for reducing the supply of new quantities of decaBDE and preventing use in any new applications.
There are currently good alternatives to using decaBDE in the applications that are to be covered by a national regulation. This assessment is valid, provided that the alternatives to decaBDE do not comprise other substances with properties that are similar to or more dangerous than decaBDE, such as other halogenated substances. The Swedish Chemicals Inspectorate’s inspection project “Flamskydd i varor 2003”[Flame protection in products 2003] indicates however that the flame retardants used most are organic phosphorous and nitrogen compounds as well as inorganic salts such as aluminium and magnesium salts.
References:
KEMI Rapport 5/04 Dekabromdifenyleter (dekaBDE) – underlag till ett nationellt förbud [Decabromodiphenyl ether (decaBDE) – basis for a national ban], Swedish Chemicals Inspectorate, Stockholm, November 2004, order no. 360 799.
KEMI PM no. 2/04, Flammskydd 2003 [Flame protection 2003], Swedish Chemicals Inspectorate, Stockholm, June 2004, order no. 510 784.
The Swedish Chemicals Inspectorate’s reports can be ordered on fax number +46-8 735 76 98, or by e-mail . The reports can also be obtained from under “trycksaker” [publications] and then “rapporter” [reports].
Memorandum / Annex 208.11.2005
Ministry of Sustainable Development
Risk assessment for decabromodiphenyl ether (decaBDE)
Contents
1. Background
2. Status of the existing risk assessment and summary of the conclusions
3. Further studies and risk-reducing measures
4. Summary of the EU’s existing risk assessment for decaBDE
4.1 Physico-chemical properties of decaBDE
4.2 Environment
4.3 Health
Risks to health and the environment
1. Background
This risk assessment aims to provide a picture of the risks to health and the environment posed by decaBDE. A risk assessment of decaBDE has been carried out within the EU’s programme for existing substances[3] and was published in 2002 (EU, 2002). The United Kingdom is the Rapporteur Member State for environmental risks and France is the Rapporteur Member State for health risks. When the risk assessment was revised in September 2005, the conclusion was that even though it has not yet been possible to identify clear risks to health or the environment the level of uncertainty is so high that there is a need for new studies. After carrying out such studies the risk assessment will be revised.
This assessment will summarise the revised risk assessment and report on its current status. The ongoing work with decaBDE within the EU as a result of the risk assessment will also be described.
2. Status of the existing risk assessment and summary of the conclusions
DecaBDE is considered to be very slow to degrade (persistent). It has also been found that decaBDE can be converted to lower brominated compounds and it was not possible to determine the extent of this in the risk assessment. In the long term this may pose a risk.
At present there is insufficient information to give a clear picture of the health and environmental risks associated with decaBDE. Therefore, in the environmental risk assessment, conclusion (i) according to the EU TGD[4] applies, i.e. “there is a need for further information and/or testing” with regard to a number of points that are very important primarily for the assessment of decaBDE as a possible PBT substance (Persistent, Bioaccumulative, Toxic). These are:
• Potential neurotoxicity
In experiments on neonatal mice, decaBDE was found to be capable of interfering with brain development when the mice were exposed during a critical period resulting in behavioural disturbances in adulthood. This may also pose a risk to bird embryos, as decaBDE has been found in bird eggs. However, the quality of the study has been called into question, and in order to check the reliability of the study it will be necessary to carry out a new study.
• Uptake by mammals
The extent to which decaBDE is taken up by mammals is uncertain. More recent studies have shown a higher uptake than previous studies, and the uptake also appears to depend on how decaBDE is administered.
• Sporadic occurrence high up in the food chain
DecaBDE has been found in, among others, peregrine falcons and their eggs. It is not known whether this is a result of the fact that decaBDE is bioaccumulative in falcons or whether they are exposed to higher levels than other species. There is no information available on trends over time. DecaBDE has also been found in Arctic polar bears but it is not known how it has spread to there.
• Degradation to more toxic substances