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Document 52016SC0290

COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Council Directive amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead

SWD/2016/0290 final - 2016/0267 (NLE)

Brussels, 9.9.2016

SWD(2016) 290 final

COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT

Accompanying the document

Council Directive

amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead

{COM(2016) 560 final}
{SWD(2016) 289 final}


COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT

Accompanying the document

Council Directive

amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead

1.Procedural issues and consultation of interested parties

1.1.Identification

1.2.Organisation and timing

1.3.Consultation and expertise

1.4.Scrutiny by the Commission Impact Assessment Board

2.Context

2.1.The Toy Safety Directive

2.2.Lead in toys

2.3.Overview of the toy sector

3.Problem definition

3.1.Children's exposure to lead - the problem that requires action

3.2.Toys containing lead - a problem driver for lead exposure

3.2.1.Possible sources for lead in toys

3.2.2.Toys actually containing lead – Results of market monitoring exercises

3.2.3.Exposure of children to lead

3.3.Consequences of exposure to lead

3.4.Scale of the problem

3.5.Who is affected, in what ways and to what extent?

3.6.Establishment of revised lead limit values

3.6.1.New scientific knowledge about lead requires revised limit values for lead in toys

3.6.2.Approach of the Toy Safety Directive: 5% of the toxicological reference value

3.6.3.Analytical feasibility of the revised limit values

3.7.Which toys are affected?

3.7.1.Types of toys affected

3.7.2.Origin of the toys affected

3.8.Estimation of health benefits and of economic costs

3.9.EU right to act

4.Objectives

4.1.General policy objectives

4.2.Specific policy objectives

4.3.Operational policy objectives

4.4.Consistency with other policies and objectives

5.Policy options

6.Analysis of impacts

7.Comparing the options

8.Monitoring and evaluation



1.Procedural issues and consultation of interested parties 

1.1.Identification 

The initiative is foreseen for adoption in 2014.

The lead DG is DG ENTR. DG SANCO, DG TRADE, DG ENV, SG and the LS are associated in the process.

1.2.Organisation and timing

This consolidated impact assessment completes the findings of an earlier impact assessment

by including newly available data on the occurrence of lead in toys (instead of assuming that all toy materials would contain lead at the height of the applicable limit value);

by using 5% of the new toxicological reference value for lead as the basis for new limit values (instead of 10%).

To support the preparation and drafting of the earlier impact assessment, a Commission inter-service steering group (IASG) was established. DG TRADE, DG SANCO, DG ENV and SG participated. The IASG met 3 times.

1.3.Consultation and expertise 

The Commission informed all concerned stakeholders (Member States, industry, consumer protection associations, standardisation bodies, Notified Bodies (NBs)) on its initiative during the meeting of the Expert Group on Toy Safety in April 2011; several Member States supported the revision of the limit values for lead. Some preferred to do so based on a Tolerable Daily Intake (TDI) allocation of 5%, another referred to a TDI allocation of 10% coupled with an exception or with a transitional period. The Expert Group did not object to the use of a TDI allocation of 10%. One Member State called for an impact assessment to be performed. Subsequently, a number of Member States expressed support for Option 3 b) (5% allocation and exemption for the Arts and Crafts toys) examined further below.

Following this, the Commission received position papers from the toy industry (Annexes V and VI), indicating that the Commission's initiative would have important impacts on the sector's competitiveness. The main impact highlighted by industry was its incapacity to continue marketing certain categories of toys. Taking this into account, the Commission further consulted the toy sector via a targeted public consultation 1 . The targeted group of stakeholders received information on the initiative and was invited to express their opinion on the identified problems, options and other relevant issues. The consultation was published on the "Your voice in Europe" portal, as well as on the DG ENTR webpage dedicated to toy safety and ran from 13 February 2012 to 07 May 2012. Additionally, business associations were informed about the consultation via email and were asked to circulate the information amongst their members. The results of the consultation were eventually published and business associations were duly informed about their publication.

The Commission also collected position papers from consumer protection associations, in particular from ANEC 2 and BEUC 3 (Annex VII). ANEC and BEUC support the revision of the limit values for lead in toys, in order to increase as much as possible children's protection against lead exposure and related health consequences.

The consultation was complemented by interviews 4 with stakeholders carried out by two external consultants in the framework of their respective studies 5 : one on health costs related to children exposure to lead via toys 6 , the other on the initiative's effects on the competiveness of the toy sector. 7  

The consultants' studies, in particular the health costs study, and thus the earlier impact assessment were based on the assumptions that

All toy materials would contain lead at the level of the applicable migration limit values 8 . However, new data available from market surveillance monitoring exercises in Germany 9 , 10 in 2010 and 2011, and from a limited market surveillance action in Sweden 11 , suggest that most of the toy materials contain only very low levels of lead, with few exceptions.

the revised limit values should be calculated starting from 10% of the new toxicological reference value for lead, namely the BMDL01 relating to neuro-developmental effects.

However, the Toy Safety Directive 2009/48/EC sets the allocation of the toxicological reference value for lead (and five further metallic elements or compounds, namely arsenic, cadmium, chromium-VI, mercury, organic tin) strictly at 5%, due to them being considered particularly toxic as referred to in recital 22 of the Directive.

This consolidated impact assessment therefore

considers that only few toys (respectively toy materials) may have to be adapted to new limit values for lead;

sets the allocation at 5% of the BMDL01.

The above two elements and their impact for the establishment of new limit values for lead in toy materials were discussed with all stakeholders at the meeting of the Expert Group on Toy Safety in May 2014. A range of Member States preferred a 5% allocation of the toxicological reference value, while others favoured 10%. Stakeholders from the toy industry and consumer representatives were equally split in their views.

1.4.Scrutiny by the Commission Impact Assessment Board

The Impact Assessment Board of the European Commission assessed a draft version of the earlier impact assessment and issued its opinion on 16 January 2013. The Impact Assessment Board made several recommendations and, in the light of the latter, the revised earlier impact assessment clarifies the regulatory framework and provides additional background on lead exposure sources. It also enhances the baseline scenario. Additional clarifications were also made as regards several tables and figures, and calculation assumptions used. Some of the arguments used to discard certain options were clarified.

Building on the revised earlier impact assessment, this consolidated impact assessment includes data on the presence of lead in toys and the origin of such toys as recently reported by Germany and Sweden and uses a 5% allocation of the toxicological reference value for lead.

2.Context 

2.1.The Toy Safety Directive 

The Toy Safety Directive 2009/48/EC (TSD) modernised the legal framework for toy safety in the EU. Applicable as of 20 July 2011 (for the chemical requirements a longer transition period has been foreseen, namely 20 July 2013) the TSD increases the level of safety for toys while ensuring their free movement on the market.

The TSD introduces strict requirements for chemical substances in toys, and allows for a constant alignment of these requirements to the latest scientific developments by means of amending the chemical provisions. It contains an obligation to systematically review the occurrence of hazardous chemicals in toys, taking into account new scientific evidence and/or concerns raised by Member States. Similar provisions exist in other pieces of legislation, e.g. the restriction of lead in jewellery is accompanied by an obligation of review 5 years after its entry into force 12 . Thus, the Commission can propose amendments to certain chemical requirements when new scientific data is made available.

In particular, the TSD contains specific migration limits for lead which are based on scientific evidence available in 2008, i.e. at the time of the legislative procedure. The current migration limits build on the Dutch National Institute for Health and Environment (RIVM) report 13 and on different scientific opinions, and they are based on the TDI, the weight of a child and the kind and amount of toy material ingested. A specific percentage of the TDI is allocated to toys, meaning that intake from toys cannot exceed 5% or 10% of the daily intake (from all sources, food and non-food products included). For lead, with an allocation of 5%, these limits are as follows: 13.5 mg/kg for toys made of dry materials, 3.4 mg/kg for toys made of liquid materials and 160 mg/kg for toys made of scraped-off materials. These limits apply only to toys where lead is accessible via sucking, licking or swallowing. Thus, they are mainly intended to protect children between 0 to 3 years of age (where such behaviour exists), but they also protect older children, when they have a similar behaviour.

Independent scientific committees appointed by the European Commission (e.g. the Scientific Committee on Health and Environmental Risks - SCHER) can evaluate scientific data provided by other scientific committees or institutions on request. This was the case for the above mentioned RIVM report, whose methodology for establishing limit values for toys was validated by SCHER in 2010.

The former Toy Safety Directive 88/378/EEC established bioavailability limits for chemicals in toys, including lead. The bioavailability level for lead, according to this directive, should not exceed 0.7 µg/day. The European standard EN 71-3 Migration of certain elements has translated this into an upper limit of migration of lead from toy material, corresponding to 90 mg/kg. This transposition was based on the hypothesis that the average intake of any toy material is 8 mg/day, whether dry, liquid or scraped-off.

2.2.Lead in toys

Toys may contain lead; it can be intentionally added in materials or present in toys due to raw materials naturally contaminated.

For example metal alloys and painted parts may be contaminated by lead. Interviews with industry associations (see Annex IV) suggest that metal parts and regular paint are not the most important sources of lead contamination. When parts and painted materials are coated and the toy material is solid (e.g., metal parts, painted plastic toys), migration of lead can occur only from scraped-off material. Modern synthetic paints, moreover, do not contain lead, unlike in the past. Dust from metal alloy parts in constructional toys (such as screws, bushings, washers) are a source of scraped-off material, but may lead to problems for industry if it is considered a powder-like material for which a tighter limit value would apply.

For liquid toys and brittle or pliable toy materials, manufacturers may incidentally use raw materials that are naturally contaminated by lead. Colouring pigments (such as titanium dioxide), and softeners or fillers (such as kaolin and clay) are used in Arts and Crafts toys such as modelling clay, colour pencils, paint tablets, powder paint, liquid finger paints and poster paints, pastels and wax crayons. These materials are often an important element in the toy (up to 80% of the material as in colour pencil leads), and have a crucial role for the technical functioning of the product (e.g., ensuring gradual abrasion without breaking, enabling opaque colouring).

According to information received from the industry (see Annex VI) there are currently no alternatives to replace lead in certain toys. This is because the presence of lead in these toys is due to naturally contaminated raw materials. There are no suitable substitutes for these raw materials either, according to the same sources mentioned above.

For the purpose of the sector's overview, liquid, sticky and brittle, dry or pliable toys will be referred to as Arts and Crafts toys. The first category of toys above falls under the heading of "Other toys".

2.3.Overview of the toy sector

There are about 2,000 companies involved in the toys and games sector in the EU. Most are small and medium-sized enterprises (SMEs). The toy industry directly employs nearly 100,000 people in the EU in production, research and development, marketing, sales, distribution, and many other services.

The total production of toys in the EU in 2010 was mostly generated by France, Germany, Italy, Ireland, Spain, the UK, Denmark, the Czech Republic, Malta and Poland.

The total exports of toys 14 from EU27 countries to non-EU countries in 2010 was €1.05 billion.  The total imports of traditional toys from non-EU countries to EU27 in 2010 was €6.96 billion.

Toys are manufactured globally but China is by far the biggest exporter of toys in the world. Some 85% of all toys on the European market are produced in China, by both EU and non-EU manufacturers. The toys that come onto the European market find their way to final consumers via different routes.

Figure 1 - Value chain for the toy sector

As depicted in the figure above, the toy value chain consists of different types of actors that each play their own distinct role. The way these various actors interact with each other depends largely on their position in the supply chain. While the bigger economic operators typically have full control over product design, manufacturing and distribution, many retailers tend to have control only over manufacturing and distribution, with traders only having control over the distribution but not in any significant way over design and manufacturing.

The picture illustrates the roles of different actors. It all starts by creating a concept and designing a toy according to the applicable legislation. Different suppliers interact, delivering the assemblies, parts or chemicals used before starting the production in a factory. The finalised product leaves the factory and is shipped to its corresponding market, e.g., the EU market. Once declared that it can freely move and be stored and sold by retailers, and toys end up on the shelves of shops. The end user, the consumer, will buy the product and take it home. In this specific case, the end users are children playing with the toys. Their number 15 is estimated at 80 million within the EU.

3.Problem definition 

3.1.Children's exposure to lead - the problem that requires action

Lead is a heavy metal which takes both organic and inorganic forms. As it naturally occurs in the earth crust, it is contained in many natural resources such as zinc ore, silver and (most abundantly) copper. Lead is also found in the air, soil, water and food 16 as the result of human activities and due to its extensive use in industrial processes.

Humans are exposed to lead via multiple sources: dietary (water, food) and non-dietary (air, soil, consumer products such as toys). The Scientific Committee on Health and Environmental Risks (SCHER) considers that the exposure to lead via toys should not exceed a maximum of 10% of the lead's daily intake (from all sources) 17 .

Lead exposure has particularly damaging effects on children, as they are in fact more susceptible to lead than adults for two main reasons:

A developing brain is more susceptible to neurotoxicity of lead than a fully-developed adult brain 18 ;

Children, especially under the age of six, absorb greater amounts of lead than adults, even when the absolute exposure to lead is identical 19 .

The figure below summarises the effects and impacts of lead exposure in children.


Figure 2 – Effects and impacts of lead exposure in children

The current lead limit values in the TSD reduce to trace levels the amount of lead which may occur in toys. Below these limit values, it is considered that exposure to lead has no critical health effects. However, these limit values, adopted in 2009, have been recently invalidated by new scientific evidence.

In 2010, the European Food Safety Authority (EFSA) 20 concluded that for lead, as a toxic metal, there is no threshold below which exposure to lead has no critical health effects. In non-human primate models, even low-level exposure to lead has caused neurotoxicity (i.e. damage to the nervous system and/or brain), in particular learning deficits.

The new toxicological reference value is the BMDL01 relating to neuro-developmental effects. The BMDL01 is the lower confidence limit (95% percentile) of the benchmark dose of a 1% extra risk of intellectual deficits in children measured by the Full Scale IQ score, i.e., a decrease in IQ by 1 point on that scale 21 . The BMDL01 is equivalent to an intake of 0.5 µg lead/kg bodyweight/day.

In light of these findings, it is necessary to revise the limit values for lead in toys.

3.2.Toys containing lead - a problem driver for lead exposure

3.2.1.Possible sources for lead in toys

Lead is present in a wide range of materials in the environment, in both organic and inorganic form (Table 3). Consequently, children may absorb lead through dietary or non-dietary exposure, and face health consequences.

Toys represent one of many channels of children’s exposure to lead.


Lead can be present in toys either because:

Lead is intentionally added to non-contaminated materials (artificial lead); or

Raw materials, which are contaminated with traces of naturally-occurring lead, without any added value for the functioning of the toy have to be used to produce the toy.

Figure 3 – Sources of lead in toys

The two most common ways in which toy manufacturers use (added) lead are:

For pigmentation in paint, rubber, plastics and ceramics. Examples of toys that could contain lead for pigmentation include painted blocks, metal cars, tea sets, etc.

As a stabiliser in PVC 22 products – for softening plastic to make it more malleable. When lead is used to soften plastic in toys, it makes the plastic degrade to lead dust on overexposure to heat, which is toxic for anyone who comes in contact with it. Examples of toys that could contain added lead as a stabiliser include toy balls, toys from vending machines, etc.

The two most common ways in which toy manufacturers use natural materials that are contaminated with traces of naturally occurring lead are:

As extenders (e.g. kaolin, chalkstone, clay, talc or other grinded rock materials), in dry or brittle colouring materials to maintain stability, breaking resistance and smoothing abrasion without scraping. Examples of toys that could contain natural materials contaminated with traces of naturally occurring lead include chalks, pencils, pens, crayons 23 – i.e. primarily in the Arts and Crafts industry.

As pigments (e.g., iron oxides, titanium dioxide, barium sulphate), in liquid or sticky materials to render them opaque. Examples of toys that could contain natural materials contaminated with traces of lead include paints 24 – i.e. primarily in the Arts and Crafts industry.

Toys that contain traces of naturally occurring lead include: chalks, coloured pencils, fibre pens, finger paints, drawing games (Spiro games), modelling materials, water colours, wax crayons, window colour, fancy products 25 .

3.2.2.Toys actually containing lead – Results of market monitoring exercises

In May 2013 data from German market monitoring programmes, carried out in 2010 and 2011, provided detailed migration data on lead in toys 26 from 2,496 toy samples tested. Tests included toys made with contaminated natural raw materials such as finger paints, colour pencil leads or water paint tablets. The results of the market monitoring are shown in the table below. Very few other data on lead in toys are available.

The table below shows that on average (see column "median"; the median is also called "50 percentile": 50% of the samples examined have a lead content that is below the 50 percentile expressed in mg lead/kg toy material. Of course the remaining 50% of the samples are above the median.) lead was not detected in the toys tested, with the exception of colour pencil leads with 1.5 mg/kg lead.

The 90 percentiles (90% of the samples tested have a lead content that is below the 90 percentile expressed in mg lead/kg toy material. The 90 percentile encompasses near to all samples.) again show some higher value for colour pencil leads (6 mg/kg), but also for water paint tablets (10.2 mg/kg).

In conclusion, the market monitoring results suggest that colour pencil leads and water paint tablets, which belong to the Arts and Crafts toys, had a somewhat higher lead content than most other toys. In all cases, however, the 90 percentile was clearly, or even considerably, below the current TSD limit values for lead.

These conclusions were supported by a limited market surveillance action in Sweden 27 regarding colour pencil leads.


Table 1 – Lead migration from 2,496 toy samples tested according to EN 71-3 in 2010 and 2011 during market surveillance monitoring programmes in Germany

Toy

Type of toy material and current TSD limit value
in mg/kg

Number of tested samples

Number of samples with a quantifiable lead content

Median
(50 percentile)

in mg/kg

90 percentile
in mg/kg

Finger paints

Liquid
3.4

63

11    (18%)

nd (<0.1)

1.3

Chalks

Dry
13.5

136

13    (9.5%)

nd (<0.25)

1.5

Modelling clays

47

10    (21%)

nd (<0.25)

2.6

Colour pencil leads

411

228    (58%)

1.5

6

Water paint tablets

424

112    (26%)

nd (<1.25)

10.2

Colour pencil coatings

Scraped-off
160

326

79    (24%)

nd (<0.25)

1.8

Rattle coatings (< 36 months)

473

165    (35%)

nd (<0.5)

2

Puzzle coatings (< 36 months)

102

47    (46%)

nd (<1.5)

4

Pull-along toy coatings
(< 36 months)

96

36    (37%)

nd (<1)

1.9

Dolls / figures

323

113    (35%)

nd (<0.5)

2.6

Wooden construction sets, shops

96

18    (19%)

nd (<0.2)

1.6

All scraped-off toy materials

1415

458    (32%)

nd (<0.5)

2

"Dry" means Dry, brittle, powder-like and pliable toy material
"Liquid" means Liquid or sticky toy material

" Scraped-off " means Scraped-off toy material

nd … not detectable (<Limit of Detection LOD, mg/kg)

3.2.3.Exposure of children to lead

There are several ways in which children can generally be exposed to lead, though some of these are deemed not particularly significant in the context of toys 28 . The table below summarises children's exposure to lead.


Figure 4 – Exposure scenario categories

The scenarios of direct ingestion and mouthing are relevant for toys. Oral exploration behaviour in children below 3 years of age implies that all sorts of toys could be both mouthed and ingested by them. Children above 3 years could also mouth toys intended to be placed in the mouth, as well as ingest scraped-off material from them.

Due to the nature of the vast majority of toys, inhalation, skin contact and eye contact are unlikely to be significant channels of children’s lead exposure, for two main reasons:

Toy characteristics: Inhalation via evaporation would imply extremely volatile chemicals, whilst inhalation via dust or spray would imply significant amounts of dust being released or chemicals being released via a spraying system. There are only very rare examples of toys fulfilling these criteria, though if they do, they are subject to the toy migration limits;

Nature of exposure: Skin contact is not a significant channel, because dermal uptake of lead is very low. Eye contact effects, such as eye irritancy, are of a mild and transient nature.

The ways in which, and the extent to which, children are exposed to lead through toys has been a key issue of interest in the scientific and policy making communities. RIVM 29 estimates that 8 mg of scraped-off, 100 mg of brittle and 400 mg of liquid or sticky toy material are ingested by a child every day. This implies that if such toys contain traces of lead, a small amount of lead will be ingested by children. As children of a young age are constantly exposed to toys, toys partially manufactured with or containing lead are a problem driver for lead exposure in children and its resulting neurotoxic effects. This is true even if the proportion of children's lead exposure due to toys is small, in particular in the context of more relevant exposure sources (i.e. water and food).

3.3.Consequences of exposure to lead

The consequences of exposure to lead manifest themselves only once the chemical is absorbed in the blood stream and accumulates in organs and tissues. Thus, the health impacts of children’s exposure to toxic metals, including lead, via toys can only be measured through the bioavailability of the material in the blood stream. Bioavailability is defined as ‘the amount of each element in the toy which could be absorbed into the systemic circulation of a child’ 30 .

Estimates of the amount of lead that can be absorbed into the blood circulation of a child can be measured taking into consideration the various steps of the digestive process. If the toy contains lead, during digestion in the gastro-intestinal tract, lead might be partially or totally released from the toy material ingested. The fraction of lead released from the toy material ingested is potentially available for transport across the intestine. Part of the lead absorbed through the intestine will be metabolised by the liver (i.e. eliminated via urine). Other part will not be metabolised and it will hence reach the blood. This non-metabolised part exerts toxicity in the organs and tissues, with consequences for the child’s health. This process is outlined in the table below.

Figure 5 – Process of bioavailability

Lead absorption can cause a number of health related and non-health related impacts. The effects of lead poisoning on human health depend on the amount of lead absorbed and the time over which this amount is absorbed. In the case of small quantities absorbed over a longer period of time, the most widespread health impacts include:

kidney damage, which manifests as a loss of function and decreased reabsorption (UNEP, 2012) 31 ;

hearing problems caused by slowed nerve conduction in the auditory pathway (Schwartz, 1991) 32 ;

behaviour and attention problems (MedlinePlus, 2011) 33 , which can manifest in ADHD (Attention Deficit Hyperactivity Disorder); and

slowed body growth (MedlinePlus, 2011).

Moreover, lead absorption might also have impacts on the individual’s quality of life, which are not necessarily health related. For instance, lead may reduce IQ and productivity 34 as a result of its effect on the nervous system, or it may affect fertility rate, through its effects on the reproductive system. Both the health related and non-health related impacts of lead absorption may imply a reduction in individual quality of life, increased treatment costs for society and generate a reduction in the individual's productivity. More evidence on these impacts is presented in Annex II.

3.4.Scale of the problem 

Lead is present in a wide range of materials in the environment, in both organic and inorganic form. Consequently, children may absorb lead through dietary or non-dietary exposure, as shown in the following table:

Table 2 - Lead exposure channels

Dietary exposure

Food

Source of lead in food primarily as a consequence of air pollution. Largest contributors to overall food lead exposure across the EU are vegetables, nuts and pulses (between 14% - 19%), as well as cereals and cereal products (13% - 14%) 35 . For young children, this particularly includes some calcium supplements, infant formulae and breast milk.

Water

Primarily from steel and iron industries, as well as from lead production and processing operations. Lead exposure via water, this is generally higher for those living near hazardous waste sites 36 .

Total Diet

For children between 0 and 7 years old, estimates of reported dietary exposure range from 0.21 to 3.10 μg/kg bodyweight per day 37 .

Non-dietary exposure

Air

Primarily from anthropogenic sources, i.e. metal production, manufacturing industries, electricity and heat production. In the USA, household lead paint and related dust and chips are a particularly large source of high lead levels in children, though less so in the EU. Bioavailability of atmospheric lead has decreased rapidly over the past forty years, because of regulations banning the usage of lead in petrol. For children, air exposure is split into outdoor air and environmental tobacco smoke. Daily outdoor air lead exposure is estimated to be between 0.001 and 0.003 μg/kg bodyweight per day in children. Daily environmental tobacco smoke lead exposure between 0.012 and 0.052 μg/kg bodyweight per day in children 38 .

Soil & Dust

Important source of lead exposure for children. This includes, e.g. lead dust in carpets and dust near waste sites. It is estimated that children are exposed to between 0.18 and 0.80 μg/kg bodyweight on a daily basis 39 .

The Scientific Opinion on Lead in Food, issued by the Panel on Contaminants in the Food Chain at the European Food Safety Agency (EFSA) 40 shows that the dietary lead exposure estimates for children exceed the new toxicological reference value BMDL01 (which is equivalent to 0.5 µg lead/kg bodyweight/day), as summarised in the table below.

Table 3 – Dietary lead exposure estimates for children and toxicological reference value

Children's age,
years

and consumption

Dietary lead exposure estimate
µg/kg bodyweight/day

How many times does the exposure exceed the BMDL01 (0.5 µg lead/kg bodyweight/day) ?

1 – 3
mean consumption

1.10 – 3.10

2 – 6

1 – 3
high consumption

1.71 – 5.51

3 – 11

4 – 7
mean consumption

0.80 – 2.61

2 – 5

4 – 7
high consumption

1.30 – 4.83

3 – 10

A lead intake at the level of the BMDL01 is considered to be the highest tolerable exposure level for lead 41 . Since the current average blood lead levels in European children are higher than this highest tolerable exposure level, and since no threshold for the neuro-developmental effects has been established, any additional exposure must be avoided as far as possible 42 .

Toys represent one of many channels of children’s exposure to lead. Whilst it is difficult to assess how much of the daily quantity of lead children are exposed to actually comes from toys, an extensive review of the relevant scientific literature on exposure channels indicates that the proportion of children’s lead exposure that is due to toys is small. In particular, this proportion must be regarded in the context of several other more significant lead channels, as depicted above.

3.5.Who is affected, in what ways and to what extent?

Children playing and being exposed to toys containing lead traces are the main affected parties. The exposure is made mainly via the mouthing and direct ingestion of toy materials containing lead. The mouthing behaviour is specific for young children aged from 0 to 3 years. Therefore they will be the main beneficiaries of the potential measures aiming at reducing levels of exposure to lead from toys. Statistics show there are 16 million children below 3 years of age in the EU 43 .

3.6.Establishment of revised lead limit values

3.6.1.New scientific knowledge about lead requires revised limit values for lead in toys

The lead limit values in the Toy Safety Directive 2009/48/EC 44 (TSD) as adopted are 13.5 - 3.4 - 160 mg/kg in dry - liquid - scraped-off toy materials, respectively. They are based on a Tolerable Daily Intake (TDI) of 3.6 µg/kg bodyweight/day 45 , 46 as the toxicological reference value. They are equally based on the requirement of the TSD that the lead intake from toys should not exceed 5% of the TDI 47 , due to the particular toxicity of lead.

Due to new scientific knowledge published by the European Food Safety Agency (EFSA), there is no longer a (lower) threshold for neuro-developmental effects from lead. Therefore there is no longer a TDI 48 , 49 .

The new basis, or toxicological reference value, for establishing a lead limit for children is the BMDL01 relating to neuro-developmental effects. The BMDL01 is the lower confidence limit (95% percentile) of the benchmark dose of a 1% extra risk of intellectual deficits in children measured by the Full Scale IQ score, i.e., a decrease in IQ by 1 point on that scale 50 . The BMDL01 is equivalent to an intake of 0.5 µg lead/kg bodyweight/day.

3.6.2.Approach of the Toy Safety Directive: 5% of the toxicological reference value

As referred to above, during the establishment of the TSD it was considered that the limit values for several elements which are particularly toxic, amongst which lead, should be set "at levels that are half of those considered safe according to the criteria of the relevant Scientific Committee" 51 .

The opinion of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) from 2004 52 recommended that toys should not contribute above a maximum of 10% of the total lead intake by children. The successor to the CSTEE, the Scientific Committee for Health and Environmental Risks (SCHER), concurred with the approach to limit the uptake to 10% of a toxicology-based reference value 53 .

The TSD therefore set the limit values for lead (and five further metallic elements or compounds, namely arsenic, cadmium, chromium-VI, mercury, organic tin) 54 at only 5% of the then existing toxicology-based reference value, the TDI 55 . Since the TDI is no longer the toxicological reference value but instead the BMDL01, the present consolidated impact assessment considers an allocation of 5% of the BMDL01.

The table below shows the limit values for lead in toys, revised in accordance with the approach of the TSD.

Table 4. Limit values for lead in toys

Toy material

Lead limits, mg/kg

Directive 2009/48/EC
as adopted

Revision:
5% allocation of the BMDL
01

Dry

13.5

2

Liquid

3.4

0.5

Scraped-off

160

23

"Dry": Dry, brittle, powder-like or pliable toy material
"Liquid": Liquid or sticky toy material

"Scraped-off": Scraped-off toy material

To note that, according to the new scientific knowledge, lead is a non-threshold substance: It exerts toxic effects even at most minor concentrations. Lead should therefore not be present in toys, and the limit values should be set, as recommended by standard EN 71-9 56 , at the lowest level achievable, which would be the Limit of Quantification (LOQ) of the analytical method applied.

This would mean that the revised limit values for lead in toys should be set at the LOQ of lead as given in EN 71-3 which is designed to test the migration of lead (and of the other metal elements and compounds listed in Annex II, section III, No. 13 of the TSD) 57 , namely at 0.122 mg/kg in any toy material.

However to keep consistency with the TSD this consolidated impact assessment considers the limit values given in the table above.

3.6.3.Analytical feasibility of the revised limit values

As referred to above EN 71-3 reports a typical Limit of Quantification (LOQ) for lead of 0.122 mg/kg. This is at least 4 times lower than the revised limit values proposed in the table above. Toys can therefore be tested for the revised limit values already today, without any investment into laboratory equipment or laboratory capacity.

3.7.Which toys are affected?

3.7.1.Types of toys affected

In May 2013 data from German market monitoring programmes, carried out in 2010 and 2011, provided detailed migration data on lead in toys 58 . Almost 2,500 toy samples were tested for lead, including toys made with contaminated natural raw materials such as finger paints, colour pencil leads or water paint tablets which belong to the Arts and Crafts toys. The results of the market monitoring are shown in the table below. Very few other data on lead in toys are available.

The table shows that the overwhelming majority of the toys tested already complied with the lead limit values derived from a 5% allocation of the BMDL01. Compliance rates varied from 91% to 100%. This reflects the variability of samples encountered in any market surveillance activity and can broadly be considered as reflecting compliance. Only finger paints, colour pencil leads and water paint tablets had lower compliance rates, namely 75%, 73% and 83%, respectively.



Table 5. Compliance of 2496 toys in market surveillance programmes 2010 – 2011 in Germany

Toy

Type of toy material

Number of tested samples

Lead limit value
mg/kg

5% allocation

%age of compliant toy samples

Finger paints

Liquid

63

0.5

75

Chalks

Dry

136

2

100

Modelling clays

47

91

Colour pencil leads

411

73

Water paint tablets

424

83

All dry toy materials

1018

82

Colour pencil coatings

Scraped-off

326

23

100

Rattle coatings (< 36 months)

473

99.6

Puzzle coating s (< 36 months)

102

100

Pull-along toy coatings
(< 36 months)

96

100

Dolls / figures

323

97.5

Wooden construction sets, shops

96

100

All scraped-off toy materials

1415

99

"Dry" means Dry, brittle, powder-like and pliable toy material
"Liquid" means Liquid or sticky toy material

" Scraped-off " means Scraped-off toy material

3.7.2.Origin of the toys affected

A detailed look at the countries of origin of those finger paints, colour pencil leads and water paint tablets 59 is given in the table further below. It reveals the following:

Finger paints: Only 55% of finger paints from one Member State complied with a 5% allocation of the BMDL01 while the figure for another was 67% and for a third, 90%. However 100% of finger paints from China or of unknown origin were compliant with such a limit value.

A simulation with a 10% allocation of the BMDL01, reflecting the opinion of SCHER 60 , again gave low compliance rates for the 3 Member States of 86%, 67% and 90% (the latter two unchanged) for finger paints. Thus many of these finger paints were non-compliant with the limit values in both simulations.

This was confirmed by analyses carried out on 3 finger paints on the Swedish market, originating from a further Member State and from China 61 . These finger paints were non-compliant in simulations with both a 5% and a 10% allocation of the BMDL01.

In conclusion, it is possible to manufacture compliant finger paints, while non-compliant finger paints on the market pose a health risk to children since they do not even comply with a 10% allocation.

Colour pencil leads: In the case of one Member State, no colour pencil leads complied with a 5% allocation of the BMDL01 while the figure for another was 60% and for a third, 65%. The figure for China was 85%, while only 71% of colour pencil leads of unknown origin were compliant with such a limit. However 100% of colour pencil leads from a further Member State and from Brazil as well as 94% identified as being ‘from Europe’ complied with the 5% allocation limit.

Under a simulation with a 10% allocation of the BMDL01 the compliance rates rose in certain cases. However for the three Member States above, compliance rates were still only 14%, 60% (unchanged) and 85%. For China it was 91% and it was 88% for colour pencil leads of unknown origin. Thus colour pencil leads from many origins remained non-compliant.

Furthermore, from 3 colour pencil leads on the Swedish market (from 2 Member States and Indonesia), only 1 was compliant with the 5% allocation, although all 3 products were compliant under a simulation with a 10% allocation.

Thus, while the data show that it is possible to manufacture in compliance with a 5% allocation of the BMDL01, the colour pencil leads of a majority of origins can be considered to pose a health risk to children since they remained non-compliant in a simulation with a 10% allocation of the BMDL01.

Water paint tablets: In the case of one Member State only 79% of water paint tablets complied with the 5% allocation of the BMDL01 (rising to only 80% with a 10% allocation). However 100% of those from two other Member States, those identified as being ‘from Europe’, those from China and those of unknown origin were compliant with such a limit. The analyses of water paint tablets on the Swedish market also showed that all 3 samples (from three further Member States) complied.

Thus the water paint tablets from a large majority of origins were compliant, while most non-compliant paint tablets on the market pose a health risk to children since they did not even comply with a 10% allocation.

In conclusion, most of the finger paints, colour pencil leads and water paint tablets which did not comply with the 5% allocation of the BMDL01 remained non-compliant even with a 10% allocation, and these toys can be considered to pose a risk to the health of children. On the other hand, it is possible for manufacturers to produce such kinds of toys that comply with a 5% allocation of the BMDL01.



Table 6. Origin and compliance rates of finger paints, colour pencil leads and water paint tablets in market surveillance programmes 2010 – 2011 in Germany

Toys and their origin

Number of tested samples

Compliant toy samples, in %

5% allocation:
limit value 2 mg/kg

10% allocation:
limit value 4 mg/kg

Finger paints

DE

29

55

86

IT

10

90

90

NL

6

67

67

China

12

100

100

Unknown

6

100

100

TOTAL

63

75

89

Colour pencil leads

DE

100

65

85

FR

12

100

100

AT

7

0

14

UK

10

60

60

Europe

16

94

94

Brazil

4

100

100

China

78

85

91

Unknown

184

71

88

TOTAL

411

73

86

Water paint tablets

DE

242

79

80

FR

3

100

100

IT

40

100

100

Europe

4

100

100

China

8

100

100

Unknown

127

84

85

TOTAL

424

83

84

3.8.Estimation of health benefits and of economic costs

In case of no action, the limits established in the Toy Safety Directive 2009/48/EC would remain unchanged, i.e. 13.5 mg/kg in dry materials, 3.4 mg/kg in liquid materials and 160 mg/kg in scraped-off materials.

Children would continue to be exposed, via toys, to a high amount of lead, which can lead to kidney damages, hearing problems, behaviour and attention problems, and slowed body growth.

These health consequences raise long-term costs related to:

a reduction in health related quality of life, measured as Quality Adjusted Life Years (QALYs) 62

an increase in health cost due to medical treatment, such as drug cost, hospital treatment cost, etc.

a reduction in productivity, measured as work days loss due to the health condition, multiplied by the average wage.

Economic costs are related to:

Increase in production costs;

Reduction in the product range. It would be difficult to continue to market certain toys (e.g. colouring pencils) as they would not meet the safety limits anymore;

Poorer quality or performance of some toys (e.g. range of colours; abrasion characteristics, etc.).

To estimate the above benefits and costs, the earlier impact assessment based its calculations on the assumptions that

All toys comply with the current TSD limit values and thus contain lead at the level of these limit values;

The allocation of the toxicological reference value for the revision of the limit values is 10%.

In contrast to this, on the basis of newly available information, this consolidated impact assessment assumes that

Toys contain lead at only a very minor level as shown further above by the market monitoring results of 2010 and 2011 in Germany, only some Arts and Crafts toys (finger paints, colour pencil leads, water paint tablets) may exceed the proposed revised limit values;

The allocation of the toxicological reference value is 5% since the current lead limits in the TSD are equally based on a 5% allocation.

Thus benefits and costs may in general only relate to the adaptation of the lead content of the Arts and Crafts toys referred to above. Since "On average, about 6.5% of toy sales in the EU are art and crafts toys (according to TIE statistics)."  63 ,

the health benefit figures of the earlier impact assessment will be multiplied with 6.5% (0.065) for the purpose of this consolidated impact assessment.

This is a very crude approach and may underestimate the health benefits, since the proposed revised limit values of this consolidated impact assessment are only half as high as the limit values proposed in the earlier impact assessment, due to the allocation of only 5% (instead of 10%). However, halved limit values do not translate into half a lead concentration in the blood of children, and also not to doubled health benefits.

On balance, therefore, it may be sufficient to retain that the health benefit figures in this consolidated impact assessment are approximate, and could be higher;

the economic costs will be left as estimated in the earlier impact assessment.

This is again quite approximate, since manufacturers of Arts and Crafts toys may have to make additional efforts to find raw materials that are even less contaminated with lead. However, efforts will not cost double as much since there is no relation between the search effort and the level of contamination. Furthermore, as shown above by the market monitoring data, there are indeed Arts and Crafts toys on the market that comply with the proposed revised lead limit values. It is therefore well possible to find appropriate raw materials and place the resulting toys at a competitive price on the market.

On balance, therefore, it may be sufficient to retain that the economic cost figures are only approximate.

3.9.EU right to act

1.Legal base

The toy safety legislation is based on Article 114 TFEU guaranteeing the functioning of the internal market.

2.Subsidiarity test

According to the principle of subsidiarity (Article 5.3 of the TFEU), action on EU level should be taken only when the aims envisaged cannot be achieved sufficiently by Member States alone and can, by reason of the scale or effects of the proposed action, be better achieved by the EU. The preceding analysis has shown that children are equally exposed to lead, and this exposure leads to health consequences. Thus, the TSD aims at guaranteeing an equal level of protection to all EU children, while eliminating obstacles to the free movement of toys with the EU market.

Individual actions undertaken by Member States, intended to protect children's health from lead exposure via toys, would result in children being unequally protected within the EU. Additionally, such individual measures could lead to a fragmentation of the internal market and create barriers to toys' trade.

4.Objectives 

4.1.General policy objectives

The general objective of this initiative is to ensure a high level of health protection, while safeguarding the free movement of goods within the EU. The absence of a common harmonised level of protection would encourage Member States to take disparate national measures to protect their consumers; such national measures would jeopardise the free movement of toys on the EU market. Germany for example considers that the limit values currently contained in the TSD are not strict enough and requested permission to apply stricter values, in order to better protect the health of children 64 .

4.2.Specific policy objectives

The specific objectives of this initiative are:

To reduce children's exposure to lead via toys by taking stock of the latest scientific findings, and

To maintain the free movement of toys within the EU.

4.3.Operational policy objectives

The specific objectives to be accomplished by this initiative are:

To apply the maximum amount of lead which should not be exceeded, and

To ensure that this maximum amount applies to all toys marketed on the EU market.

4.4.Consistency with other policies and objectives

At EU level, the presence of lead in ceramics and plastic materials which come into contact with food is already restricted 65 . The REACH Regulation bans the use of lead compounds in paint 66 . The presence of lead and its compounds in jewellery is also restricted, in order to reduce health risks 67 . Lead is also restricted in foodstuffs (major source of exposure) by Regulation 1881/2006 68 . For example, the maximum amount allowed in milk is 0.020 mg/kg and in cereals 0.20 mg/kg. In drinking water (other major source of lead exposure), the Drinking water directive establishes a maximum amount of 10 µg/l as from December 2013. With regard to drinking water in particular, the Scientific Committee on Health and Environmental Risks (SCHER) recommends, in its 2011 opinion on lead in drinking water, a further reduction of the lead exposure as a warrant for the reduction of the risks on health. Further restrictions for lead are being considered in the framework of the Codex Alimentarius 69 and a so-called Annex XV dossier has been submitted by Sweden under the REACH Regulation for the purposes of restricting lead and its compounds in articles which are supplied to the general public and can be placed in the mouth by children, if the concentration of lead (expressed as metal) in the article is equal to or greater than 0.05% by weight. As regards the classification of lead at EU level for adequate risk management, Sweden submitted a proposal for a harmonised classification of lead as a reprotoxic substance 70 . The use of lead in food and non-food products is internationally restricted as well. In the US for example, lead in not allowed in toys and child care articles at concentrations above 100 ppm. In drinking water, the Safe Drinking water Act sets out a maximum contamination goal of 15 ppm.


Figure 6 – Problem and objectives tree

5.Policy options 

The policy options as proposed by the Commission and as consulted with stakeholders are the following:

Baseline option: Maintaining children's exposure to lead via toys at the level determined by the TSD in 2009, without taking into account the evolution of the lead related scientific knowledge. The limit values to be maintained are as follows: 13.5 mg/kg in dry materials, 3.4 mg/kg in liquid materials and 160 mg/kg in scraped off materials.

Option 1: Soft law / self-regulatory approach: Inviting the toy industry to put in place voluntary agreements on reducing lead exposure via toys.

Option 2: Labelling of toys containing lead in order to raise awareness amongst consumers on the health risks due to exposure to lead via toys.

Option 3: Revision of the current limit values for lead. This option presents three alternatives (sub options):

Option 3a): Complete revision of the current limit values: reducing the limit values for lead in all toys and all categories of toy material in line with the latest scientific knowledge,

with mitigating measures;

with no mitigating measures.

This option would imply the following limit values: 2 mg/kg in dry materials, 0.5 mg/kg in liquid materials and 23 mg/kg in scraped-off materials.

Option 3b): Partial revision of the current limit values: reducing the limit values for lead in all toys and all categories of toy material in line with the latest scientific knowledge except those toys made with raw materials naturally contaminated with lead. This option would imply the following limit values: 2 mg/kg in dry materials, 0.5 mg/kg in liquid materials and 23 mg/kg in scraped-off materials, except for clay, kaolin, pigments and others, where the limits would remain as follows: 13.5 mg/kg in dry materials, 3.4 mg/kg in liquid materials and 160 mg/kg in scraped-off materials.

Option 3c): Revision of the current limit values according to feasibility: reducing the limit values for lead in all toys, in line with what is feasible for the industry according to the current state of the art. This option is based on EWIMA's position paper (Annex VI). This option would imply the following limit values: 9 mg/kg in dry materials, 3.4 mg/kg in liquid materials and 50 mg/kg in scraped-off materials.

Sub-options for mitigating measures:

Option3a) I - Extended transitional period for the Arts and Crafts industry, due to the negative economic impacts expected. This will allow more time for putting in place innovative solutions to replace certain raw materials for example.

Option 3a) II - Extended transitional period for SMEs, for which the costs will be higher than for larger companies.

Option 3a) III - Exemption of SMEs from the new limits.

6.Analysis of impacts 

The impact assessment will focus on economic and social impacts. Those will be assessed in relation to economic operators involved in the manufacturing and marketing of toys, and in relation to children exposed to lead via toys.

Environmental impacts will not be assessed in this impact assessment. Environmental protection per se is not within the objectives of the Toy Safety Directive (TSD). The disposal of toys is governed by a number of existing Directives such as WEEE 71 , ROHS 72 , the Waste Directive 73 and Packaging and Packaging Waste 74 . Other relevant horizontal legislation includes the Batteries Directive 75 and REACH 76 . No direct environmental impacts are thus expected from this initiative under the TSD.

Social impacts

Social impacts in this specific case translate into health impacts and impacts on employment.

Health impacts translate into benefits for children's health. The main benefits expected are:

an increase in health related quality of life (measured as quality adjusted life years QALYs, because there would less lead exposure exerting toxicity and causing diseases);

a decrease in health costs due to medical treatments that can be avoided (such as drug costs, hospital treatment costs, etc., because there would be less lead exposure which could otherwise exert toxicity and cause diseases);

an increase in productivity (because there would be less work days lost due to otherwise poor health condition).

The assessment of the health impacts is based on the assumption that 100% of toys subject to the EU legislation would comply with it. This assumption is based on evidence suggesting that a very small percentage of toys tested fail to meet the current requirements in terms of chemical substances 77 .

In addition, this consolidated impact assessment assumes that only a limited range of toys, namely some Arts and Crafts toys referred to further above (finger paints, colour pencil leads and water paint tablets), would exceed the proposed revised lead limit values.

This assessment further takes into account that the children most exposed are those below 3 years of age, because of their pronounced mouthing behaviour. Their number is estimated at 16 million in the EU (see the assumptions in more detail in Annex II and Annex IX).

Impacts on employment translate into jobs lost in the toy sector. Higher compliance costs may provide incentives for offshoring production, in order to reduce labour costs. One can assume that these are mainly design and marketing related jobs, as most of the toy production is outsourced. Affected Member States are those where most of the toy companies are established (e.g. Italy, France and Germany).


Economic impacts

Economic impacts translate into costs for the economic operators. These costs are estimated to be higher for SMEs than for big companies as higher production costs combined with a smaller range and scale of product lines increase the unit costs more. Three types of costs are important for the present analysis, according to the consultation's findings:

Raw material costs implying the search for higher quality raw materials, which are more rare and thus more expensive. These costs are one-time adaptation costs.

Analytical costs imply the costs related to quality control procedures for the production process and final product. This involves the testing of raw materials and ultimately the toy material itself. Testing can be done in house or externally. Such testing may face various difficulties and may become complex and more costly if lead limits are reduced. First, higher quality raw material (i.e. raw materials with a low lead content) does not necessarily ensure lower lead migration in toy material. Second, the toy must meet the migration limits for other chemical elements which may also be present. Natural raw materials may contain up to 90 chemical elements, and the TSD regulates 19 of them. Thus, the raw materials may contain less lead, but still have to comply with limit values for other chemical substances in order for the final toy to be compliant. These analytical costs may imply also training costs to adapt to more complex testing procedures and possibly costs for new testing equipment. Some of these costs, such as new testing equipment and training are one-time adaptation costs. All the others are considered as recurrent costs.

Concerning the testing costs for lead as such, compliance testing for the reduced limit values for lead proposed in this consolidated impact assessment should be possible already today and thus without additional costs, because the Limit of Quantification (LOQ) for lead according to EN 71-3 is 4 times lower than the lowest limit value proposed;

Developmental costs imply the development of toys that can meet the reduced migration limits and retain their technical function. Reformulation of products by use of substitute materials, such as artificial pigments, may impair the quality of use of the product (e.g. the breaking resistance of colouring pens). These costs are considered as being recurrent costs. This is because human and physical capital needs to be replaced over time. Testing costs are fixed production costs per product in the toy catalogue, but they are recurrent over time for quality control and monitoring reasons. Material related costs are variable costs of production.

Additionally, these costs are putting pressure on budgets for new product development and thus on the sector's capacity to innovate (in terms of the costs of research and development involved).

On the upside, higher health and safety standards offer opportunities for marketing toys by referring to enhanced safety for small children (combined with their educative role). This could also be an asset on the global market, where consumer safety regulation is often less strict. According to the results of the public consultation (Annex III), 21% of respondents consider that tightening the limit values for lead will improve their competitive position on the market due to the enhanced quality of their products.

Due to a lack of representative quantitative information on some of the impacts, qualitative statements were the best available data on which the report had to base itself. The quantifications, i.e. a thorough analysis has been carried out for the impacts deemed the most relevant (i.e. health impacts and economic cost impacts). Other impacts, in particular those related to the competitiveness of the toys sector have been acknowledged but could only be underpinned with qualitative statements.

The baseline option

Economic impacts

The baseline option will not imply any additional costs for economic operators, testing laboratories nor national authorities in charge of market surveillance, because no change compared to the current applicable situation is expected. The current situation (namely the new TSD adopted in 2009) generated economic costs amounting to 26 million euro 78 .

Social impacts

a)    Health impacts

The baseline option will not bring about any improvement to the protection of children's health. Children will continue to be exposed to lead via toys since they ingest toy material due to their mouthing behaviour. Part of the lead contained in the ingested material will remain in the child's body, and will be absorbed into his/her blood - the bioavailability fraction of lead.

This bioavailability fraction of lead exerts toxicity and causes health consequences such as: kidney damages, hearing problems, behaviour and attention problems and slowed body growth. The related health costs will remain. The baseline option results in a life time total health costs of € 9,234 million for ADHD and € 6,526 million for IQ. 79  No additional health benefits are expected from the baseline option (see Annex I and II for the explanation of calculations).

b)    Impacts on employment

The baseline option will not imply any job losses in the toy sector, as no change compared to the current applicable situation is expected. The current situation (namely the new TSD adopted in 2009) was estimated to generate around 200 job losses, accounting for 2.5 million euro 80 . There are, of course, no incremental benefits expected from the baseline scenario.


Table 7 - Summary of monetised costs for the baseline option

Baseline scenario

Total costs (million)

Total benefits (million)

Economic impacts

26

ADHD

Reduced IQ

Social impacts

2.5

9,234

6,526

Option 1) Soft law / self-regulatory approach: While a voluntary agreement may present some advantages for economic operators such as manufacturers or distributors, it risks not being the most time efficient, because of its non-binding character. It also raises major uncertainties as to the sector capacity to self-regulate, even if the industry showed an excellent record on compliance, following enforcement activities carried out by Member States. This record on compliance refers to mandatory rules established by legislation. There is no certainty that this compliance record would have been the same in the case of non-mandatory rules. Considering that optional rules, without any enforcement (or sanctions) possibilities, would not be equally respected appears as a logical assumption, especially when most of the toy production is based in China, where we register the highest level of non-compliance. This is supported by the results of the joint market surveillance action results published in 2010, showing that 64% of the toys not complying with the toy safety chemical requirements were coming from China. RAPEX reports also show that the share of Chinese non-compliant toys found on the EU market is very important (e.g., 54% in 2011).

Companies tend to maximise their profit and this does not come hand in hand with fully protecting consumers. Assuming that self-regulation would take place in a certain sector, uncertainties still exist as to the number of economic operators willing to implement the measures, and thus as to the real benefits for children's health. Finally, the health of children is a too important and too sensitive issue to be left unregulated. Thus, this option has been discarded and will not be assessed further.

Option 2) Labelling of toys containing lead may imply fewer costs for economic operators, as it is less expensive to put in place labelling systems than ensuring compliance with newer and stricter safety rules. Also, evidence shows that information to consumers is a vital part of any product. Labelling increases the consumer's awareness and its ability to make a reasoned choice. It also increases the provider's commercial reputation.

However, research on the way consumers would perceive warnings and other type of information provided is necessary before introducing them. Such research should be done across consumers from all social, economic and cultural groups, in order to test if the level of perception is similar and to judge the usefulness of such warnings or labelling. In the meantime, children would continue to be exposed to a high amount of lead exerting toxicity and resulting in diseases.

It is noteworthy that consumers are not fully aware about the presence of lead in consumers' products and the related health consequences. Therefore labelling or warning on toys only could be misleading and disproportionate for the consumer, as the main exposure to lead comes from food and air, where such labelling is currently neither provided nor foreseen. Parents buying toys would believe that the presence of lead and its health consequences is an issue specifically related to toys, while this is a general problem concerning all exposure sources (food and non-food sources). Additionally, such warnings, if present, would be reaching the appropriate target to be protected – children – only indirectly, as they would be addressed at parents, not at children. Parents are the ones generally concerned by warnings, as they are the ones to buy toys. However, there is no information currently showing how such labelling would reach parents or care takers, as depicted above.

Additionally, in relation to lead exposure, one cannot fully rely on labelling and warnings recommending adult supervision. Adult supervision even if fully applied, cannot fully prevent lead exposure. Thus, this option has been discarded and will not be assessed further.

Option 3) Revision of the current limit values for lead 

This option will imply additional costs for certain economic operators as well as health benefits the magnitude of which will vary depending on the selected sub-option.

Sectors upstream the toy manufacturing industry in the value chain would not be affected much by policy option 3). The toy industry is a small client for mining companies providing the raw materials. They would not be impacted by policy option 3) because they provide several qualities to large industrial clients across various sectors. Mining firms do not market their materials, such as kaolin and clay, specifically for toys producers. They choose a suitable material from the available product range as price takers. For similar reasons, policy option 3) also hardly affects manufacturers of pigments and colorants.

Testing facilities would see an increase in demand from toy manufacturers as a result of policy option 3). They will need to test different qualities of raw materials and intermediates to assess whether they meet the chemicals related requirements, including those on lead. Testing facilities may need some more sophisticated equipment to reach the required accuracy and reliability, particularly for liquid toys such as paints. Because testing laboratories may need to make additional investments specifically for the analysis of toys, the number of facilities that will continue to offer services to toy manufacturers may decline, and the price level of external testing may increase.

Downstream in the value chain, wholesale and retail providers are not likely to be very much affected. Apart from small and specialized retail shops, retailers offer a wide spectrum of toys and Art and Crafts products.

Consumers may be able to purchase certain products (e.g. colouring pencils), which participate to the development of children's creativity, if these go out of the market. They may shift their expenditure to other toys and games, at least partly.

Option 3a) Complete revision of the current limit values

Economic impacts

Industry would be affected in its capacity to market certain toys, made from naturally lead contaminated raw materials. Industry sees three major threats to their competitive position following Option 3a):

Increase in production costs;

Reduction in the product range. It would be difficult to continue to market certain toys (e.g. colouring pencils) as they would not meet the safety limits anymore;

Poorer quality or performance of some toys (e.g. range of colours; abrasion characteristics, etc.).

The costs would be higher for SMEs, for which possibly more complex testing procedures and the costly search for suitable raw materials, combined with a smaller range and scale of product lines, increase unit costs more. Furthermore, SMEs are more focused on local markets, rather than exports to third countries. This may limit the marketing advantage of child safety. Next to this, additional marketing and product development costs will put a bigger strain on SMEs resources, being fixed costs.

On the positive side, SMEs stand to benefit more if option 3) lowers competition on the EU market and lose less if competition increases on export markets. This is because SMEs are more focused on local markets rather than export to third countries. SMEs are not less likely to pass on a cost increase into prices. This can reflect that they occupy a niche in a monopolistically competitive market. If this niche is mostly local, relatively sheltered from price competition, pass-on of costs is possible. Free entry and high competition may lead to zero profits in the long run. Costs then will be passed on into prices via the mechanism of entry and exit of firms. Prices would need to increase to reflect cost increases; demand would fall and fewer firms would survive. This is supported by the SMEs views expressed during the public consultation 81 - SMEs represented 70% of the respondents to the public consultation.

According to Ecorys (Annex VIII), policy option 3a) results in an estimated impact that would amount to 89 million euro of production value. The worst case scenario would be a de-facto ban of certain toys (e.g. colouring pencils) based on the industry declarations that natural materials cannot consistently meet the lead migration limits (at least not without violating some other regulation on chemical elements 82 ) and substitutes are not readily available. This potential ban may lead to further loss of production up to a total displacement of these toys in the EU. This would imply a loss of 217 million euro.  

However, the ban of certain toys from the market following option 3a) is not an absolute certainty. Position papers from industry association claim that some toys could be banned from the market following option 3a), but there are currently no means for Member States or the Commission to verify whether this statement is fully reliable. Furthermore, this statement is not fully supported by the results of the public consultation. When replying to questions related to policy option 3a), certain toy manufacturers state that they will be able to continue manufacturing those toys, while others acknowledge not knowing yet if this will be still possible or not.

As regards the marketing of the same products labelled "not toys", suggested by stakeholders, this option is not possible. The directive sets out a clear definition of a toy (products intended, whether or not exclusively, to be use in play by children under 14 years of age). All products entering into this category are de facto toys, and economic operators cannot circumvent this legal classification by labelling them as not being toys.


Social impacts

a)    Health impacts

Option 3a) Complete revision of the current limit values presents the highest benefits for children's health, as the exposure to lead via toys will be reduced by lowering the levels of lead. This reduction of the bioavailability fraction of lead would result in an incremental benefit compared to the baseline option of:

Table 8 - Incremental benefits of option 3a)

Benefits

Baseline option

Option 3a)

ADHD

IQ

ADHD

IQ

Health benefits

Lifetime treatment cost of ADHD

€ 220

-

€ 200

-

Lifetime treatment cost of mother caring for a child with ADHD

€ 41

-

€ 38

-

Quality of life s (QALY)

Lifetime health related quality of life quality of life

€ 165

-

€ 150

-

Productivity benefits

Productivity cost associated with mother caring for a child with ADHD

€ 96

-

€ 87

-

Productivity cost associated with child

€ 55

€ 408

€ 50

€ 334

Unit cost per child

€ 577

€ 408

€ 525

€ 334

Total cost (€m)

€ 9,234

€ 6,526

€ 8,399

€ 5,350

Incremental benefit per child

€ 52

€ 73

Total Incremental benefit (million)

€836

€1,176

For details on the health benefits calculations see Table 2 of the relevant study (in Annex I).

The health benefits shown in the table above are 6.5% of the benefits calculated in the relevant study (in Annex I). For explanation see section 3.8 of this consolidated impact assessment.

It is important to stress that it is not possible to aggregate the benefits related to ADHD and those related to the IQ because the relationship between lead and health and non-health impacts is not mutually exclusive. For example, the effect of lead on ADHD could affect the IQ which has an impact on productivity. Alternatively, a child can experience an IQ impact with no experience of ADHD which also impacts productivity. The relationship between ADHD and IQ is not considered, therefore, aggregating these figures could lead to double counting of benefits.

b)    Impact on employment

According to the Ecorys study (Annex VIII), policy option 3a) results in an estimated impact that would amount to 662 lost jobs, representing 8.5 million euro. The worst case scenario - a de-facto ban of certain toys – would amount to 2,112 lost jobs representing 27.5 million euro. These estimations are based on wage costs, and the share of personnel in production costs is used to compute wage costs.

Industry challenged this policy option. According to the results of the public consultation and position papers received from industry associations (see Annexes III, V and VI), this option would lead to the potential ban of certain toys from the market. This is because these toys are made with raw materials naturally lead contaminated, and suitable substitutes are not available.

This policy option is however supported by consumer associations, in particular ANEC and BEUC (see Annex VII). While acknowledging that certain toys made with naturally contaminated raw materials (e.g. colouring pencils, finger paints) are important for the development of children’s creativity and therefore should also be available in the future, ANEC and BEUC consider that children's safety cannot be compromised.

Table 9 - Summary of monetised costs and benefits for Option 3a)

Option 3a)
Complete revision

Total costs (million €)

Total benefits (million €)

Economic impacts

89

ADHD

Reduced IQ

Social impacts

8.5

836

1,176

Sub-option 3a) I - Extended transition period for the art and crafts industry would bring about an unequal situation among economic operators manufacturing and marketing toys made from naturally contaminated raw materials and other economic operators manufacturing and marketing toys. The latter would also be affected by the measures, although not to the same extent as their toys would not risk to be banned from the market, but would not be able to benefit from the transitional period granted. Also, there is no certainty that an extended transitional period would benefit industry for searching and finding any substitutes for naturally contaminated raw materials. Thus, at the expiration of the extended transitional period, art and crafts manufacturers may face the same situation, while children continued to be exposed to a high amount of lead resulting in health risks. These health risks are associated with important impacts on health as shown in the health benefits tables above and below. Thus, this option has been discarded and will not be assessed further.

Sub-option 3a) II - Extended transitional period for SMEs and Sub-option 3a) III - Exemption of SMEs from the new limits would strongly undermine the benefits generated by the measures. SMEs are predominant in the toy sector. Available statistics show that they represent 85% of the companies involved in toy manufacturing and marketing. Thus, the measures would apply only to 15% of toys companies, and the intended health benefits would be limited to their market share only. Thus, these options have been discarded and will not be assessed further.

Option 3b) Partial revision of the current limit values

Economic impacts

The costs for the industry would be less significant than for option 3a), as toys made from naturally contaminated raw materials would be exempted from the revision of the current limits. The industry would be exposed to a tightening of the safety rules on lead, without facing a potential ban of some of their products.

As regards impacts on SMEs, testing facilities wholesale and retail providers and consumers, the same considerations as under policy option 3a) are applicable.

According to the Ecorys study (Annex VIII), policy option 3b) would result in an impact on production which amounts to 41 million euro.

Social impacts

a)    Health impacts

Option 3b) partial revision of the current limit values would bring about partial improvement to children's health, as they will be less exposed to lead via certain categories of toys. However, they will continue to be exposed to toys containing naturally lead contaminated raw materials. These toys are estimated to constitute around 6.5% of the global toys market share. The reduction of the bioavailability fraction of lead would result in incremental benefits compared to the baseline option as given in the table further below.

For the purposes of fine-tuning the calculation of benefits, a sensitivity analysis has been carried out. The two most important variables, the probability and the prevalence rate with regard to ADHD and reduced IQ have been updated. The financial assumptions (e.g. discount rates) have been reviewed and the prices used in the study for monetization proposes (from 2007) adjusted to 2012 prices. This analysis (see Annex IX) aims at providing a range of values of potential benefits according to changes in the prevalence of the illness. The key conclusions are as follows:

the total benefit resulting from a change in the prevalence of ADHD will amount to 984 million euros for Policy Option 3a), and 935 million euros for Policy Option 3b). When considering a 55% probability of continuing ADHD throughout the adulthood, the benefit generated is 49 million euros.

the total benefit resulting from a change in the prevalence of reduced IQ will amount to 982 million euros for policy option 3a) and to 936 million euros for policy option 3b). Even a minor decline of reduced IQ (e.g. 0, 80 % would still deliver significant benefits in the scale of 65 million Euros.


Table 10 - Incremental benefit of option 3b)

Benefits

Baseline Option

Option 3b)

ADHD

Reduced IQ

ADHD

Reduced IQ

Health cost benefits

Lifetime treatment cost of ADHD

€ 220

-

€ 201

-

Lifetime treatment cost of mother caring for a child with ADHD

€ 41

-

€ 38

-

Quality of life s (QALY)

Lifetime health related quality of life quality of life

€ 165

-

€ 151

-

Productivity benefits

Productivity cost associated with mother caring for a child with ADHD

€ 96

-

€ 87

-

Productivity cost associated with child

€ 55

€ 408

€ 50

€ 338

Unit cost per child

€ 577

€ 408

€ 527

€ 338

Total cost (€m)

€9,234

€6,526

€8,440

€5,410

Incremental benefit per child

€ 50

€ 70

Total Incremental benefit (million)

€ 794

€ 1,117

For details on the health benefits calculations see Table 2 of the relevant study (in Annex I).

The health benefits shown in the table above are 6.5% of the benefits calculated in the relevant study (in Annex I). For explanation see section 3.8 of this consolidated impact assessment.

b)    Impact on employment

In terms of employment, this option would generate 330 jobs lost, representing 3.9 million euro.

Table 11 - Summary of monetised costs and benefits for Option 3b)

Option 3b)
Partial revision

Total Costs (million €)

Total Benefits (million €)

Economic impacts

41

ADHD

Reduced IQ

Social impacts

3.9

794

1,117

Option 3c) Revision of the current limit values according to feasibility 

This option would bring about a situation where health measures are not based on available scientific evidence and appropriate risk assessment methods, but are arbitrarily established on the basis of the Art and Crafts industry's statement of its capacity to find low-lead (or even lead-free) raw materials. Additionally, limiting the measures to what is considered to be feasible at the time of the measures will not trigger any incentive such as looking into better raw materials, substitute materials, innovative products and reducing lead exposure. Furthermore, children's exposure to lead would remain important, generating health risks. These health risks lead to important health impacts. Thus, this option has been discarded and will not be assessed further.

7.Comparing the options 

Table 12 - Summary of economic and social impacts

Economic and social costs (million €)

Health benefits 83 (million €)

Baseline option

Production costs

Job losses

ADHD

Reduced IQ

26

2.5

9,234

6,526

Total economic costs: 28.5

9,234

6,526

Option 3a) Complete revision

Production costs

Job losses

ADHD

Reduced IQ

89

8.5

836

1,176

Total economic costs: 97.5

836

1,176

Option 3b) Partial revision

Production costs

Job losses

ADHD

Reduced IQ

41

3.9

794

1,117

Total economic costs: 44.9

794

1,117

The table above shows that the current TSD already provides considerable health benefits (some € 9 billion regarding ADHD, some € 6.5 billion regarding the IQ) with regard to the old Toy Safety Directive 88/378/EEC. At the same time the economic and social costs were relatively low (some € 30 million).

Both option 3a) (= revision of the limit values for all toys) and option 3b) (= revision of the limit values for all toys with the exception of the Arts and Crafts toys) provide health benefits which are an order of magnitude higher than the estimated economic costs. Comparing them shows for option 3a) € 42 million higher benefits regarding ADHD, and € 59 million higher benefits regarding IQ. Thus the IQ benefit increase alone is higher than the increase in economic costs, which is € 53 million. The increase in ADHD benefits is € 42 million. This speaks in favour of option 3a).

Further health benefits from strengthened lead limit values for toys may arise from avoiding other health related consequences, as referred to in section 3.3 of this consolidated impact assessment. These benefits have not been quantified here, but their occurrence supports further the choice of option 3a) as the one providing the highest health benefits.

A summary of the options regarding the health benefits, economic costs and effectiveness considerations is given in the table below.

Table 13 – Summary table comparing the options

Option

Health benefits

Economic costs

Effectiveness

Baseline scenario – No change to TSD

Although an improvement in terms of children's health will follow from the implementation of the TSD (compared to the old TSD), children will continue to be exposed to an amount of lead scientifically proven to be harmful.

Since the current limits already entered into force in 2013, the industry would incur no additional costs.

There is a danger of possible fragmentation of the toys market in the Arts & Crafts area, due to some Member States establishing national limits according to the latest scientific findings.

Option 3a) Complete revision of the lead limit values: Adoption of limit values based on a 5% allocation of the BMDL01

This option would assure the highest level of health protection of children in the EU.

Although most toy producers would be unaffected, this option would entail some adaptation costs for the affected Arts & Crafts producers.

The most positive balance of health benefits and negative economic impacts.

The complete alignment of the lead limits with the latest scientific findings would prevent Member States from taking individual actions which might potentially lead to market fragmentation.

Option 3b): Partial revision of the current lead limit values: Adoption of limit values based on a 5% allocation of the BMDL01

This option would assure a high level of health protection of children in the EU.

This option will entail lower costs for the affected industry than Option 3a).

A similarly positive balance of health benefits and negative economic impacts as option 3a).

There remains a danger of possible fragmentation of the toys market in the Arts & Crafts area, due to some Member States establishing national limits according to the latest scientific findings.

8.Monitoring and evaluation 

No new monitoring and evaluation tools are foreseen specifically for this initiative. The TSD contains an obligation for Member States to send to the Commission a report on the application of the Directive, including its amendments. Such report has to be sent by July 2014, and every five years thereafter. It has to contain an evaluation of the situation concerning the safety of toys and of the effectiveness of the Directive, as well as a presentation of the market surveillance activities performed by each Member State. Member States will in particular report on the following indicators: number of controls performed, number of non-compliant toys found and number and nature of measures taken against economic operators.

Following these reports, the Commission has to draw up and publish a summary of the national reports.

These enforcement actions foreseen by the TSD will apply also to this initiative.

(1) http://ec.europa.eu/enterprise/sectors/toys/public-consultation-lead/index_en.htm  
(2) The European consumers voice in standardisation
(3) The European consumers association
(4) http://ec.europa.eu/enterprise/sectors/toys/documents/index_en.htm#h2-7  
(5)  Options considered by the IASG constantly evolved through discussions. Therefore, not all external consultants had the opportunity to include all the changes of the options in their studies and assess them comprehensively.
(6) http://ec.europa.eu/enterprise/sectors/toys/files/reports-and-studies/final-report-lead-in-toys-matrix-insight_en.pdf  
(7) http://ec.europa.eu/enterprise/sectors/toys/files/reports-and-studies/final-report-lead-in-toys-ecorys_en.pdf  
(8)   http://ec.europa.eu/enterprise/sectors/toys/files/reports-and-studies/final-report-lead-in-toys-matrix-insight_en.pdf , p. 31: factor F2 which "is regulated by the migration limit set at the EU level ".
(9) German Ministry of Economic Affairs, Position paper on lead, 31 May 2013. See Annex XI to this consolidated impact assessment.
(10) German Ministry of Economic Affairs, Position paper on lead, 2 October 2013. See Annex XII to this consolidated impact assessment.
(11) Swedish Chemicals Agency (Kemi). Data made available in December 2013.
(12)  Commission Regulation (EU) No 836/2012, OJEU L 252, 19.9.2012, p. 4
(13)  http://www.rivm.nl/bibliotheek/rapporten/320003001.pdf
(14) Traditional toys not including video games
(15) Number of children below 14 years, who are covered by the TSD
(16) European Food Safety Agency (EFSA) http://www.efsa.europa.eu/en/efsajournal/pub/2831.htm  
(17) SCHER Opinion on the Evaluation of the Migration Limits for Chemical Elements in Toys, 2010, http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_126.pdf  
(18) Lindsky and Sehneider, 2002
(19) It has been estimated that for a given oral dose of lead, children absorb three times the quantity that adults absorb, and retain six times as much. Goyer, RA (1991): Toxic effects of metals. In Amdur Mo, Doull J. & Klaassen CD (Eds.), Casarett and Doull’s Toxicology: the Basis Science of Poison, Fourth Edition. New York, NY, Pergamon Press.
(20) EFSA 2010, http://www.efsa.europa.eu/en/efsajournal/pub/2831.htm  
(21) EFSA CONTAM Panel (2013) Scientific Opinion on Lead in Food, p. 5, p. 98.
(22) Polyvinyl chloride (PVC) is the third most widely produced plastic.
(23) WECF, 2009
(24) EWIMA,2011
(25) See Annex VI, EWIMA position paper
(26) German Ministry of Economic Affairs, Position paper on lead, 31 May 2013. See Annex XI.
(27) Swedish Chemicals Agency (Kemi). Data made available in December 2013.
(28) RIVM, 2008, http://www.rivm.nl/bibliotheek/rapporten/320003001.pdf  
(29) RIVM, 2008, http://www.rivm.nl/bibliotheek/rapporten/320003001.pdf  
(30) Scientific Committee on toxicity 2004, http://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out235_en.pdf  
(31) UNEP (Undated), Lead Exposure and Human Health. Available at http://www.chem.unep.ch/pops/pdf/lead/leadexp.pdf [Access on February 2012]
(32) Lead, blood pressure, and cardiovascular disease in men and women. Schwartz J Environ Health Perspect. 1991 February
(33) MedLine Plus (2011), Lead poisoning. Available at:
  http://www.nlm.nih.gov/medlineplus/ency/article/002473.htm [Accessed November 2011]
(34) EFSA 2010, http://www.efsa.europa.eu/en/efsajournal/pub/2831.htm  
(35) EFSA 2010, http://www.efsa.europa.eu/en/efsajournal/pub/2831.htm  
(36) EFSA 2010, http://www.efsa.europa.eu/en/efsajournal/pub/2831.htm  
(37) EFSA 2010, http://www.efsa.europa.eu/en/efsajournal/pub/2831.htm  
(38) EFSA 2010, http://www.efsa.europa.eu/en/efsajournal/pub/2831.htm  
(39) EFSA 2010, http://www.efsa.europa.eu/en/efsajournal/pub/2831.htm
(40) http://www.efsa.europa.eu/en/efsajournal/doc/2831.pdf
(41) ECHA Committee for Risk Assessment (RAC) (2013) Opinion on an Annex XV dossier proposing restrictions on lead and its compounds in articles intended for consumer use. Adopted on 10 December 2013. ECHA/RAC/RES-O-0000003487-67-04/F. http://echa.europa.eu/documents/10162/d6026d8c-3ebb-4507-bd8f-d1c942493075  
(42) ECHA RAC (2013) Opinion on an Annex XV dossier proposing restrictions on lead and its compounds in articles intended for consumer use.
(43) 16,011,195 million children. http://ec.europa.eu/enterprise/sectors/toys/files/reports-and-studies/final-report-lead-in-toys-matrix-insight_en.pdf . P. 46.
(44) Directive 2009/48/EC on the safety of toys. OJ L 170, 30.6.2009, p. 1.
(45) RIVM Report 2008, pp. 114, 120-122. http://www.rivm.nl/bibliotheek/rapporten/320003001.pdf
(46) µg/kg bw/day … microgram per kilogram bodyweight per day
(47) Recital 22 of the Toy Safety Directive 2009/48/EC. OJ L 170, 30.6.2009, p. 1.
(48) EFSA CONTAM Panel (2013) Scientific Opinion on Lead in Food. EFSA Journal 8(4), 1570 (replaces EFSA's opinion of 2010)
http://www.efsa.europa.eu/en/efsajournal/pub/1570.htm  
(49) SCHER (2011) Opinion on a Lead Standard in Drinking Water. – The opinion is largely based on the EFSA CONTAM Panel (2010) opinion, replaced by the Panel's opinion of 2013 (see footnote above).
http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_128.pdf
(50) EFSA CONTAM Panel (2013) Scientific Opinion on Lead in Food, p. 5, p. 98.
(51) Recital 22 of the TSD.
(52) Scientific Committee on toxicity 2004, http://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out235_en.pdf  
(53) Scientific Committee on Health and Environmental Risks (SCHER), Opinion on the "Evaluation of the Migration Limits for Chemical Elements in Toys", adopted on 1 July 2010.
http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_126.pdf
(54) TSD Annex II, Part III, point 13.
(55) National Institute for Public Health and the Environment (RIVM), Chemicals in Toys - A general methodology for assessment of chemical safety of toys with a focus on elements. RIVM report 320003001/2008. Table 8-1 TDIs and sensitising potential for the different elements (p. 114) and tables 8-2, 8-3 and 8-4 (pp. 120 – 122).
(56) EN 71-9:2005+A1, Annex A, section A.10.
(57) EN 71-3:2013, Table E.5.
(58) German Ministry of Economic Affairs, Position paper on lead, 31 May 2013. See Annex XI.
(59) German Ministry of Economic Affairs, Position paper on lead, 2 October 2013. See Annex XIII.
(60) 10% would still be in line with the opinion of SCHER (2010) Opinion on the "Evaluation of the Migration Limits for Chemical Elements in Toys", adopted on 1 July 2010. See footnote above.
(61) Swedish Chemicals Agency (Kemi). Data made available in December 2013.
(62) The quality-adjusted life year (QALY) is a measure of disease burden, including both the quality and the quantity of life lived.
(63)   http://ec.europa.eu/enterprise/sectors/toys/files/reports-and-studies/final-report-lead-in-toys-ecorys_en.pdf . P. 69.
(64)  OJEU, 28.5.2011, C 159, p. 23.
(65) Commission Regulation (EU) No 10/2011, OJEU L 12, 15.1.2011, p. 1
(66) Regulation (EC) No 1907/2006 (REACH), OJEU, L 396, 30 December 2006
(67) Commission Regulation (EU) No 836/2012, OJEU, L 252, 19.09/2012, p.4
(68)  OJEU, L 364, 20.12.2006, p.5
(69) http://www.codexalimentarius.org/
(70) http://echa.europa.eu/harmonised-classification-and-labelling-consultation/-/substance/698/search/+/term
(71)  Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE).
(72)  Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (ROHS).
(73)  Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives.
(74)  European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste.
(75)  Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC.
(76)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
(77) In the last 4 years, RAPEX has only reported 64 toys infringing the migration limits set by Directive. The Joint Market Surveillance Action on TOYS coordinated by PROSAFE in 2006 shows similar results.
(78)  The impact of the 2009 revision of the Toy Safety Directive was assessed in 2007: http://ec.europa.eu/enterprise/sectors/toys/files/toys_final_report_30_july_2007_en.pdf . The costs considered were financial costs (administrative, distributional, manufacturing and comitology costs) and other economic costs (enforcement and compliance costs and costs of delay to innovation and in authorisation). Ecorys (Annex VIII) estimated the order of magnitude of the most likely impact of the 2009 revision of the Directive on production of a loss in competitiveness on the domestic and global markets at 26 million euro.
(79) http://ec.europa.eu/enterprise/sectors/toys/files/reports-and-studies/final-report-lead-in-toys-matrix-insight_en.pdf
(80) http://ec.europa.eu/enterprise/sectors/toys/files/toys_final_report_without_annexes_en.pdf
(81) http://ec.europa.eu/yourvoice/ipm/forms/dispatch?userstate=DisplayPublishedResults&form=leadintoys
(82) The presence of lead in toys and other consumer articles is regulated based on content or migration. Raw materials may comply with a content limit but not with a migration limit and vice versa (e.g. a material may have a high content but only a small amount would migrate and vice versa)
(83) It is not possible to aggregate these savings; aggregating them could lead to double counting of benefits.
Top

Brussels, 9.9.2016

SWD(2016) 290 final

COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT

Accompanying the document

Council Directive

amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead

{COM(2016) 560 final}
{SWD(2016) 289 final}


COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT

Accompanying the document

Council Directive

amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead

ANNEX I CALCULATION OF BIOAVAILABILITY OF LEAD

ANNEX II ECONOMIC ANALYSIS: BEHAVIOURAL AND ATTENTION PROBLEMS (ADHD) MODEL

ANNEX III REVISION OF THE LIMIT VALUES FOR LEAD IN TOYS

ANNEX IV INTERVIEWS WITH STAKEHOLDERS - ECORYS

ANNEX V TIE COMMENTS ON THE POSSIBLE LOWERING OF LEAD MIGRATION LIMITS

ANNEX VI STATEMENT FROM EWIMA CONCERNING EUROPEAN DIRECTIVE 2009/48/EC: FURTHER REDUCTION OF LEAD MIGRATION LIMITS

ANNEX VII ANEC/BEUC POSITION ON REDUCING CHILDREN'S EXPOSURE TO LEAD FROM TOYS

ANNEX VIII COMPETITIVENESS PROOFING TOY RELATED INDUSTRY IMPACT OF NEW LEAD MIGRATION LIMITS ON THE COMPETITIVENESS OF EUROPEAN MANUFACTURERS56

ANNEX IX SENSITIVITY ANALYSIS57

1.Introduction59

1.1 Scope of the Analysis59

1.2 Key conclusions59

2.Prevalence of ADHD - Sensitivity analysis of sub-model60

2.1 Financial assumptions60

2.2 Assumptions on the Prevalence of ADHD61

2.3 Assumptions Treatment costs and productivity loss62

2.3.1 Lifetime treatment costs of ADHD for child62

2.3.2 Lifetime treatment costs of mother caring for child with ADHD64

2.3.3 Productivity loss of mother caring for child with ADHD65

2.3.4 Productivity loss of adult ADHD patient66

2.3.5 Lifetime QALY loss associated with ADHD in childhood and adulthood67

2.4 Number of children aged 1 - 3 years69

2.5 Total benefit due to reduction in the ADHD prevalence69

2.6 Sensitivity analysis on (a) the change in prevalence of ADHD and (b) on the probability childhood ADHD continues into adulthood71

3.IQ sub-model - Sensitivity analysis74

3.1 Assumptions for parameters for IQ sub-model74

3.2 Total lifetime earnings: annual earnings75

3.3 Sensitivity analysis: Percentage decrease in earnings for a 1 unit decrease in IQ , and change in IQ due different policy options.78

ANNEX X SME TEST81

ANNEX XI Position Paper from Germany regarding the revision of the lead limit values for toys82

ANNEX XII Further feedback from Germany: Origin of the 2,496 toy samples tested for their content of lead89

ANNEX XIII GLOSSARY96

 ANNEX I

CALCULATION OF BIOAVAILABILITY OF LEAD

Appendices 9.4 and 9.5 to the Matrix Report available under

http://ec.europa.eu/enterprise/sectors/toys/files/reports-and-studies/final-report-lead-in-toys-matrix-insight_en.pdf



ANNEX II

ECONOMIC ANALYSIS: BEHAVIOURAL AND ATTENTION PROBLEMS (ADHD) MODEL

Appendix 9.6 to the Matrix Report available under

http://ec.europa.eu/enterprise/sectors/toys/files/reports-and-studies/final-report-lead-in-toys-matrix-insight_en.pdf  



ANNEX III

REVISION OF THE LIMIT VALUES FOR LEAD IN TOYS

http://ec.europa.eu/yourvoice/ipm/forms/dispatch?userstate=DisplayPublishedResults&form=leadintoys



ANNEX IV

INTERVIEWS WITH STAKEHOLDERS - ECORYS

Annex III to the Ecorys Report available under

http://ec.europa.eu/enterprise/sectors/toys/files/reports-and-studies/final-report-lead-in-toys-ecorys_en.pdf  



ANNEX V

TIE COMMENTS ON THE POSSIBLE LOWERING OF LEAD MIGRATION LIMITS

At the meeting of the Expert Working Group on Chemicals (8th December 2010), TIE was asked to find out more about the US views on the feasibility of lowering the US total lead limit from 300mg/kg to 100mg/kg. Please find attached a copy of the Toy Industry Association’s (TIA) submission to the Consumer Product Safety Commission (CPSC).

TIE would like to take this opportunity to re-iterate that the EU toy industry association (TIE) takes the view that the existing EU approach that sets “heavy element” restrictions based upon migration should be maintained. Migration is a measure of exposure and hence measures the risk posed. Setting restrictions based upon total concentration is unscientific and deals only with the intrinsic hazard of a substance and does not directly measure risk.

The experts of the working group on chemicals have calculated revised migration limits for lead based upon bench mark dose data in the EFSA report on lead in food 1 . These revised limits for migration of lead from toy materials are as follows:

22mg/kg for scraped-off

2mg/kg for dry, brittle powder-like, pliable

0.5mg/kg for liquids, pastes

TIE requests that the Commission discusses this approach with all Member States and stakeholders and verify whether it is scientifically valid because it will result in the banning of important toy types such as finger paints, paints, crayons, inks etc.

Such toys would be banned because certain raw materials cannot be obtained in a sufficiently pure state owing to naturally occurring background traces of lead.

TIE has consulted with members on the impact of the revised lead limits and the wider effects are summarized below.

Ban of liquid toys such as liquid paints, poster paints, finger paints, crayons.

A 0.5mg/kg limit will mean that these toys would fail the lead migration test because critical raw materials like kaolin and titanium dioxide inevitably have naturally occurring traces of lead.

For chalks, powder paints and crayons that also use the same raw materials as paints, there will be problems satisfying the proposed limit of 2 mg/kg and these toys could also be banned.

Ban on the use of alloys like brass

Materials like the metal brass will be potentially banned from use. From EN71-3 testing data already available and information provided in the TIA submission to the CPSC, a 22mg/kg limit for scraped-off materials will be exceeded by some metal alloys that have a low level of lead such as brass. It is possible to find brass in toys in bushings, washers, screws, ferrules on tips of writing instruments etc.

Impractical to use certain recycled materials

The use of recycled plastics and recycled metals would be risky in that it is difficult to obtain sufficiently pure raw materials that will reliably meet a 22mg/kg limit.

Exposure of lead from food and toys

From information sent to the Expert Working Group on Chemicals, we can compare toys with drinking water (WHO proposed limit 10µg/L) and calculate that:

For a child less than 1 year old it will drink on average 467 ml drinking water per day (US figures) giving rise to a potential total lead consumption of 4.7µg (467ml x 10µg/L)

In the case of a liquid toy, we assume 400mg ingested per day (RIVM study). Using the proposed migration limit of 0.5mg/kg we can calculate a potential total lead exposure of 0.2 µg (400 mg x 0.5 mg/kg):

We can conclude that the protection regime for toys is over 20 times stricter than for drinking water.

Poorer Reliability of laboratory testing

Although there is not a problem detecting 0.5mg/kg lead in “clean” liquids using modern analytical equipment, the situation is different when the liquid is a paint and has to be tested using the EN71-3 migration test. As the maximum permitted limits are lowered the EN71-3 migration test method will inevitably suffer from even more inter-laboratory variation than it does at present with today’s limits. There is good evidence to show that laboratories (including Notified Bodies) are struggling to get good inter-laboratory agreement when applying EN71-3. Even lower limits will make the problem worse and give rise to legal uncertainty as to the compliance of a toy or material.

Lower limits for lead will mean that analytical equipment like ICP-MS and AAS with graphite furnace will be required by test houses. This is expensive technology and not straight forward to operate, again exacerbating the issue mentioned above.

There are significant downsides to obliging test houses to re-equip:

1) Cost per test will increase as labs seek to recoup their investment

2) Fewer test houses will offer this testing, so prices may rise further

3) Factories that possess in-house laboratories will not be able to justify this level of investment in equipment and staff. In this case the monitoring they perform will be to higher limits and so offer no legal certainty of conformity. The assurance on conformity with the lower limits will have to be through a test conducted at a suitably equipped test house.

It will also be the case that XRF screen testing will be less useful because it will more frequently detect lead above the lower thresholds, which will necessitate laboratory testing. This questions the usefulness of the screen test.

Materials believed to be unaffected

Non-metals, surface coatings, virgin plastics and textiles, should be capable of meeting a 22mg/kg limit.

Conclusion

In conclusion, TIE believes the approach that uses a benchmark dose level from the EFSA report on lead in foods, should be reconsidered. The very low limits for liquid toys and powder-like materials will ban toys such as finger paints, poster paints, liquid paints and powder-like materials such as powder paints, crayons and chalks.

Considering that the proposed restrictions on lead are much more stringent than for lead in drinking water, TIE believes the proposed restrictions go too far and are wholly disproportionate to the implied risk.

The proposal to lower the lead limit for scraped-off materials to 22mg/kg will preclude the use of some materials but the wider impact will be negligible.



ANNEX VI

STATEMENT FROM EWIMA CONCERNING EUROPEAN DIRECTIVE 2009/48/EC:

FURTHER REDUCTION OF LEAD MIGRATION LIMITS

The manufacturers of art & craft materials and other colouring products classified as toys are deeply concerned that again a tremendous reduction in lead migration limits is discussed on a European level - especially concerning dry, brittle, pliable materials/toys and liquid materials/toys.

It is already a highly sophisticated task for manufacturers of the writing instruments industry to find adequate natural or man-made materials and to reformulate their products to ensure that art & craft materials and colouring products classified as toys comply with the current migration limits for lead of 13.5 mg/kg for dry, brittle or pliable materials / toys and 3.4 mg/kg for liquid materials / toys as well as with the respective migration limit of any other element.

In leads of coloured pencils, solid materials intended to leave a trace (e.g. chalks, wax crayons, pastels) or in water paint tablets, extenders are necessary for physical and mechanical properties, e.g. stability, breaking resistance and smooth abrasion without scrapping (up to 80% of a lead/solid painting media). Extenders are also used in viscous paints, e.g. finger paints (EN 71-7, Annex C).

Consistently in the whole industry, Kaolin (synonym: china clay, porcelain clay) - a natural product - is used as extender. Alternative materials are also from natural sources, e.g. chalkstone, talc or other grinded rock materials.

Several quality levels of Kaolin for industrial or consumer products from different mining resorts all over the world are available on the market.

Simple technical Kaolin qualities are not suitable for a use in toys (total lead content up to 4000 mg/kg), because the toys would not comply with legal requirements in Europe or in the US. Due to the natural variability in lead content from a natural material, suppliers refrain from providing confirmation / certification concerning total lead limits or migration limits.

Commonly, the element contamination of materials is delivered as total lead content by suppliers depending on the mining site:

Dedicated qualities of Kaolin used in toys ranges between 70 mg/kg and 100 mg/kg lead.

The lead content of Kaolin ("good quality") is in a range of 40 - 50 mg/kg lead.

The lead content of Kaolin, marketed as "low in lead" or "very low in lead" is described as < 25 mg/kg.

Other suitable materials from natural sources, e.g. processed titanium dioxide (e.g. total lead content 60 mg/kg) or iron oxide - a widespread used pigment - are also containing lead.

It is likely that a substantial "dilution effect" concerning lead can not be expected due to the high amounts of extenders and pigments in the products.

Results of element migration analyses done by independent laboratories or by writing instruments manufacturers:

Due to third party / notified body certificates for materials or finished products, lead migration is often described as <2 mg/kg or < 5 mg/kg (according to EN 71-3).

However, results based on the detection limits of current analytical methods are neither helpful for a manufacturer's assessment concerning marketability of his product nor it is helpful for the current discussion.

Current studies of writing instruments manufacturers on lead migration from several qualities of Kaolin used in toys result in 2 mg/kg lead to 16 mg/kg lead (see Table, p3).

Thereby not only the element content vary from batch to batch, also element's migration oscillate in a considerable range. A correlation between total lead content and lead migration can not be made. Natural material "low" or "very low" in lead do not necessarily lead to low or very low lead migration!

Migration of lead from a common talc is analysed to be 3 mg/kg.

Considering the analytical results, art & craft materials as well as colouring products are invariably unable to comply with the planned lead migration limits for dry, brittle or pliable materials of 2 mg/kg or the planned limits for liquid materials of 0.5 mg/kg.

As already mentioned in earlier statements of EWIMA (European Writing Instruments Manufacturers Association), exposition of certain elements including lead derive from natural sources in considerable amounts, due to their natural widespread occurrence on earth.

The natural "contamination" of materials or substances like kaolin from natural sources is technically unavoidable.

Referring to art & craft materials and other colouring products, alternative materials without lead content are not available since they are also from natural sources. Up-dated or innovative technical processes solving the problems are not technically feasible in the medium term.

The writing instruments manufacturers realize much to their surprise that the planned migration limits for liquid materials (when measured directly in the liquid) are at a similar level as lead contamination in foodstuff (see European Regulation (EC) No. 1881/2006).

A comparison of art & craft materials or other colouring products classified as toys with foodstuff in terms of risk exposure seems to be inadequate!

Art & craft materials and other colouring products classified as toys are not intended to be regularly consumed. They are neither foodstuff, nor does any information point on a numerous accidental consumption of such products by children.

The proposed restrictive migration limit is unjustified regarding intended use and foreseeable exposure of children. An explicit accidental consumption would be attributed to the same level as a long life daily consumption by the diet.

With respect to the proposed threshold limit values for lead, the manufacturers expect a massive, very likely restrictive impact on art & craft materials and colouring products currently classified as toys which are established in the market. As the proposed limits could not be matched for the foreseeable future, these well-established products stand no chance to be marketed as toys any longer.

In summary, the writing instruments manufacturers would like to suggest the following migration limit values for materials from natural sources - taking into account the natural variability in lead content and lead migration inside the mining site:

dry, brittle, pliable materials: 9.0 mg/kg lead

liquid materials: 3.4 mg/kg lead

scraped off materials: 50 mg/kg lead

Table: Examples of lead migration analyses and total lead content analyses from natural sources (independent laboratories, writing instruments manufacturers):

Kaolin/Clay

Natural Mineral Deposit
(Country)

Lead – Migration
according to EN71-3

(mg/kg)

Lead – Total Content

(mg/kg)

Kaolin

D

3 – 8

29 – 58

Kaolin

E

2 – 3

54 – 88

Kaolin

NZ

16

<25

Kaolin

TR

4

91

Clay (grinded)

CN

4

42



ANNEX VII

ANEC/BEUC POSITION ON REDUCING CHILDREN'S EXPOSURE TO LEAD FROM TOYS

Introduction

The European Commission is currently discussing a revision of the limit values for lead in toys. With regard to drawing material, four options are under consideration: 1) no policy change, 2) a self regulatory approach, 3) a partial revision of current limit values which would exempt lead containing raw materials (clay, kaolin or pigments) used in coloured pencils, chalks, wax crayons, pastels or in water paint tablets and 4) a complete revision of current limits reducing the limits for lead in all categories of toys and toy materials.

The Commission is arguing that option 4 which is most feasible for children's health would lead to a ban of coloured pencils, chalks, wax crayons, pastels or in water paint tablets as they cannot meet higher standards. The industry is claiming more stringent lead values for dry, brittle, pliable materials and for liquid materials will make disappear many drawing materials from the market.

In spring, the Commission carried out a public consultation which was only addressed to economic operators1. In parallel, the Commission is looking into the health related effects.

In this position paper, ANEC and BEUC reply to an invitation from the Commission to contribute our views primarily with regard to the specific sub-question of lead exposure stemming from drawing materials such as coloured crayons.

The exposure of children to lead needs successfully to be lowered

ANEC and BEUC criticized for many years that the limit values for heavy metals including for lead in the Toy Safety Directive are inappropriate to protect the safety of consumers.

The exposure of children to even low levels of lead is concern as it is neurotoxic, accumulates in the body and may be an endocrine disrupter. The exposure to lead even at very low levels is thus associated with a number of potential very severe chronic and lifelong negative health consequences such as:

Damaging children's nervous system and brain development;

Causing hyperactivity;

Leading to learning disorders.

As lead is toxic, and children are exposed to it through various channels such as the inhalation and ingestion through food and drinking water but also toys, minimizing exposure to levels as low as reasonably achievable (ALARA principle) is urgently needed.

The European Food Safety Agency has pointed out that the current TDI is inadequate as exposure of children to lead through food consumption is already too high to exclude negative health effects. Moreover, EFSA pointed out that it is not possible to establish a safe limit value for lead for the critical endpoints such as neurotoxicity and the endocrine system. Hence, a TWI (Tolerable Weekly Intake) or a TDI (Tolerable Daily Intake) cannot be set.

To protect better children's health, we call for a massive reduction of current limit values by a factor of 7 based on a 5% allocation2.

Coloured pens and paints are important for children's development but should not jeopardize children's health

Coloured pencils, wax crayons and other drawing materials can play an important role for the development of children's creativity. Therefore we are, of course, in favour of ensuring that those articles can be made available to children also in future presumed they can be made in such a way that they do not jeopardize children's health. A general exemption of drawing material from lower lead levels for toys is not the right way forward. If they cannot be made safe, it could also mean that they ultimately need to be banned.

Manufacturers are requested to make data available and for these data to be checked by independent parties

We doubt based on manufacturer's replies and on product test results from our member organisations that all those drawing materials would disappear from the market as they would be unable to meet stringent threshold limits for lead. Just half of the respondents (43) to the public consultation consider that certain toys have to be banned whilst 33 do not know and 5 do not expect this would be needed.

Furthermore, the results of the Commission public consultation shows that many manufacturers do use raw materials containing lead (39), little less manufacturers (28) do not make use of such raw materials and a considerable number of respondents does not know (14) if lead is present. This finding can be confirmed by several tests on toys of ANEC and/ or BEUC member organizations that have been carried out in recent years. In all tests there are toys with large differences concerning the content and release of hazardous chemicals including on lead3.

Manufacturers who claim that they cannot produce lead free drawing materials should make relevant information available e.g. to the sub-working group on chemicals in toys for an in- depth discussion and consideration.

Likewise, information should be made available to stakeholder concerning the possible economic impacts and development of prices for consumers. The public consultation of economic operators does not give a clear picture. Although a majority (63 out of 81) expect an increase in costs, 8 expect no increase in costs and 10 respondents do not know.

We recommend that the Commission carries out an independent assessment of the situation and not only to rely on claims of manufacturers.

Our recommendations

While we see drawing materials to be important for the development of children's creativity and therefore should also be available in the future, safety cannot be compromised and in case those items cannot be made safe, they ultimately might need to be taken off the market.

The EU Commission should:

Favour option 4, i.e. carry out a complete revision of current limits reducing the limits for lead in all categories of toys and toy materials.

Carry out an independent assessment of the situation as we cannot rely on the accuracy of manufacturer's replies to a public consultation when deciding on the level of safety for children.

ANEC and BEUC call for a massive reduction of current limit values of lead by a factor of 7 based on a 5% allocation.

Endnotes

The results can be found here:

http://ec.europa.eu/yourvoice/ipm/forms/dispatch?userstate=DisplayPublishedResults&form=leadintoys

ANEC position paper on SCHER opinion: Evaluation of the migration limits for chemical elements in toys (July 2010), ANEC-CHILD-2010-G-093, http://www.anec.eu/attachments/ANEC-CHILD-2010-G-093.pdf

The Swiss FRC tested in 2011 carnival make-up for children including coloured crayons. Some of the products were free of lead and one contained up to 3.8 mg/kg lead. German Stiftung Warentest tested colouring pencils, wax crayons and other drawing materials with regard to the release of heavy metals. No pencil contained lead in core and lacquer (threshold 10 mg/kg Pb). With regard to water paint tablets, 10 out of 11 contained no lead but one contained 270mg/kg Pb.

Table 214 Benefits from the Treatment costs and productivity loss    

Table 215 - Sensitivity analysis on the Change in prevalence of ADHD and on Probability childhood ADHD continues into adulthood    

Table 31 - Reduction in IQ    

Table 32 - Change in IQ due to PO1, Percentage decrease in earnings for a 1 unit decrease in IQ    

Table 33 - Total lifetime earnings: annual earnings    

Table 34 - Change in lifetime earnings due to reduction in IQ per child    

Table 35 Sensitivity analysis: Percentage decrease in earnings for a 1 unit decrease in IQ , and Change in IQ due to Policy Options.    



1.    Introduction

1.1 Scope of the Analysis

The present appendix aims at reviewing the economic analysis section of the Matrix study and updating with regard to the following aspects:

Reviewing the financial assumptions (e.g. discount rates) and adjusting the prices used in the study for monetization proposes to the 2012 prices. The prices included in the study were the 2007 prices and therefore needed to be adjusted.

Providing a sensitivity analysis for changes in the prevalence rate with regard to ADHD and IQ. The critical parameters for the financial analysis are the incidence rates and the prices assumed for the medical costs and productivity losses of mothers, children and adults.

From the economic point of view, the relevant parameter for sensitivity analysis is the prevalence of the illness. The current appendix aims at providing a range of values of potential benefits according to changes in the prevalence of the illness. For simulation proposes, the present appendix

1.2 Key conclusions

Considering (a) the adjusted values of the cost used for monetization and (b) the change in the discount rate, the total benefit resulting from a change in prevalence of ADHD will amount to:

15,134 million euros for Policy Option 1, equivalent to a per capita benefit per child of 931 euros

14,377 million euros for Policy Option2, equivalent to a per capita benefit per child of 884 euros.

The changes in prevalence of ADHD of 0.02282%, at a 55% probability of continuing ADHD throughout the adulthood (as assumed by the Matrix Study), will generate a benefit of 757 million euros.

The sensitivity analysis concerning the IQ sub-model shows that:

A change in IQ from 0.0970 to 0.1020 due to Policy options 1 and 2, assuming a 2% decrease in earnings for every one unit decrease in IQ would lead to benefits between 14.4 billion euros to 15.1 billion euros.

even minor changes in IQ (0.0170) and even if we consider only a 0,80% decline in earnings due to a decrease in IQ it would still deliver significant returns in the scale of 1 billion Euros.



2.    Prevalence of ADHD - Sensitivity analysis of sub-model

2.1 Financial assumptions

Table 01 Discount rate

Parameter

Assumption

Discount rate =

4.00%

Soure: Impact Assessment Guidelines

The IA support study considers a discount rate of 3.5%, while de IA guidelines recommend the use of a 4% discount rate which, will from this point of view reduce the overall size of the estimated benefits.

Table 02 Inflation: EU 27 Price index 2007=100 for 2005-2011

 

2005

2006

2007

2008

2009

2010

2011

European Union (27 countries) 2005= 100

100.00

102.31

104.73

108.56

109.63

111.91

115.38

European Union (27 countries) 2007= 100

95%

98%

100%

104%

105%

107%

110%

Source: Eurostat

We have maintained the inflation rate of 2,7% as proposed by the study for the period 2012 onwards.

Table 03 Inflation Forecast 2012 onwards

 

2012 onwards

Inflation forecast =

2.70%



2.2 Assumptions on the Prevalence of ADHD

Table 04 Assumptions on the Prevalence of ADHD

Prevalence of ADHD 0.2 ug/dl – 0.8 ug/dl

3.40%

Average prevalence of ADHD =

5.29%

% of children at 0.2-0.8 ug/dl =

20.20%

% of children at 0.8-1.3 ug/dl =

29.60%

% of children > 1.3 ug/dl=

50.20%

Relative risk of ADHD 0.8 ug/dl to 1.3 ug/dl =

1.49

Relative risk of ADHD > 1.3 ug/dl =

1.82

Prevalence of ADHD 0.8 ug/dl – 1.3 ug/dl

5.06%

Prevalence of ADHD 0.2 ug/dl – > 1.3 ug/dl

6.18%

Unit prevalence of ADHD change per 0.01 change in ug/dl (for > 1.3 ug/dl)

0.02282%

(4ug/dl-1.3ug/dl)/0.1ug/dl)+1)

271

Probability childhood ADHD continues into adulthood

55.00%

Lifetime QALY loss associated with ADHD in adulthood Annual QALY loss =

0.070

Lifetime QALY loss associated with ADHD in childhood Annual QALY loss =

0.09

Source: Matrix Study

Table 05 Change in prevalence of ADHD due to Policy Options

Policy Option 0

Policy Option 1

Policy Option 2

μg lead/day

1.35

0.40

 

Blood lead level in children

3.50

3.30

3.31

Decrease in blood lead level associated with

 

0.20

0.19

Change in prevalence of ADHD due to

 

0.4564%

0.43%

Source: Matrix Study

We have maintained all the assumptions presented in the study concerning the average prevalence, a risk of prevalence, and unit prevalence of ADHD change per 0.01 change in ug/dl (for > 1.3 ug/dl), which is the result of the use of the US EPA Integrated Exposure Uptake BioKinetic (IEUBK) model and amounts to 0.02282%. As a next step we will present and demonstrate the cost associated with the illness and the underlining cash flows to measure the total costs for the society of the changes in prevalence. After obtaining those data we will be able to present the simulation of the impact on costs depending on the changes in the ADHD prevalence rates.

2.3 Assumptions Treatment costs and productivity loss

Table 06 Assumptions Treatment costs and productivity loss 2007-2012

 

2007

2008

2009

2010

2011

2012

Annual treatment cost of ADHD - Euros =

1,340

1389

1454

1554

1712

1758

Annual treatment cost of a mother caring for a child with ADHD - Euros =

832

862

903

965

1063

1091

Annual productivity loss of a mother caring for a child with ADHD =

1,932

2003

2096

2240

2468

2534

Annual cost per worker

4,221

4,375

4,580

4,894

5,392

5,537

Annual number of work days lost Euros =

33.5

33.5

33.5

33.5

33.5

33.5

Cost per work day lost = €

126

131

137

146

161

165

Monetary value of a QALY

23,929

24804

25965

27745

30566

31391

1 year - 3 years

15270

15448

15629

15870

16057

16490

Productivity loss of adult ADHD patient

€ 19,994

20725

21695

23182

25540

26229

Source: Matrix study / DG ENTR Calculations

The reference values for 2007 were adjusted to 2012 prices using the assumptions presented in section 2.1 (Financial assumptions.)

2.3.1 Lifetime treatment costs of ADHD for child

The annual treatment cost of ADHD in euros at 2012 price levels is estimated to be of 1 758 per year. Considering a period of 62 year of average, the estimated lifetime treatment costs of ADHD for each child would be in the range of 76 963 euros (using as explained above a 4% discount rate and an inflation rate of 2.7%).

Table 07 - Lifetime treatment costs of ADHD for child

 

Annual treatment cost of ADHD - Euros

discount factor

CF -Discounted annual treatment costs

NPV = Σ Discounted annual treatment costs

0

1758

1.00

1758

1758

1

1805

0.96

1736

3494

2

1854

0.92

1714

5208

3

1904

0.89

1693

6901

4

1956

0.85

1672

8572

5

2008

0.82

1651

10223

6

2063

0.79

1630

11853

7

2118

0.76

1610

13463

8

2175

0.73

1590

15053

9

2234

0.70

1570

16622

10

2295

0.68

1550

18172

11

2356

0.65

1531

19703

12

2420

0.62

1512

21215

13

2485

0.60

1493

22707

14

2553

0.58

1474

24181

15

2621

0.56

1456

25637

16

2692

0.53

1437

27074

17

2765

0.51

1419

28494

18

2840

0.49

1402

29896

19

2916

0.47

1384

31280

20

2995

0.46

1367

32647

21

3076

0.44

1350

33996

22

3159

0.42

1333

35329

23

3244

0.41

1316

36646

24

3332

0.39

1300

37945

25

3422

0.38

1284

39229

26

3514

0.36

1268

40497

27

3609

0.35

1252

41748

28

3706

0.33

1236

42984

29

3807

0.32

1221

44205

30

3909

0.31

1205

45410

31

4015

0.30

1190

46600

32

4123

0.29

1175

47776

33

4235

0.27

1161

48936

34

4349

0.26

1146

50083

35

4466

0.25

1132

51214

36

4587

0.24

1118

52332

37

4711

0.23

1104

53436

38

4838

0.23

1090

54526

39

4969

0.22

1076

55602

40

5103

0.21

1063

56665

41

5241

0.20

1050

57715

42

5382

0.19

1036

58751

43

5527

0.19

1023

59775

44

5677

0.18

1011

60785

45

5830

0.17

998

61783

46

5987

0.16

986

62769

47

6149

0.16

973

63742

48

6315

0.15

961

64703

49

6485

0.15

949

65652

50

6661

0.14

937

66590

51

6840

0.14

926

67515

52

7025

0.13

914

68429

53

7215

0.13

903

69332

54

7410

0.12

891

70223

55

7610

0.12

880

71103

56

7815

0.11

869

71972

57

8026

0.11

858

72830

58

8243

0.10

848

73678

59

8465

0.10

837

74515

60

8694

0.10

826

75341

61

8929

0.09

816

76157

62

9170

0.09

806

76963

Source: Matrix study and DG ENTR Calculations

2.3.2 Lifetime treatment costs of mother caring for child with ADHD

After adjusting the 2007 reference value of annual treatment cost of a mother caring for a child with ADHD of 832 euros per year to 2012 prices and considering a care period of 15 years, we arrive at a lifetime treatment costs of mother caring for child with ADHD of 15 918 euros per child.

Table 08 - Lifetime treatment costs of mother caring for child with ADHD

 

Discount factor

Annual treatment cost of ADHD - Euros

CF -Discounted annual treatment costs

NPV = Σ Discounted annual treatment costs

0

1.00

1091

1091

1091

1

0.96

1121

1078

2169

2

0.92

1151

1064

3234

3

0.89

1182

1051

4285

4

0.85

1214

1038

5323

5

0.82

1247

1025

6347

6

0.79

1281

1012

7360

7

0.76

1315

999

8359

8

0.73

1351

987

9346

9

0.70

1387

975

10321

10

0.68

1425

962

11283

11

0.65

1463

950

12234

12

0.62

1503

939

13172

13

0.60

1543

927

14099

14

0.58

1585

915

15014

15

0.56

1628

904

15918

Source: Matrix Study, DG ENTR Calculations

2.3.3 Productivity loss of mother caring for child with ADHD

Annual productivity loss of a mother caring for a child with ADHD was estimated in 2007 at 1 932 euros which at 2012 prices represent an estimated loss of productivity amounting to 2 534 euros and during a 15 years period will represent a total loss of 36.963 euros per child.

Table 09 Productivity loss of mother caring for child with ADHD

 

Discount factor

Annual productivity loss of a mother- Euros

CF -Discounted annual productivity loss of a mother

NPV = Σ Discounted annual productivity loss of a mother

0

1.00

2534

2534

2534

1

0.96

2603

2503

5037

2

0.92

2673

2472

7509

3

0.89

2745

2441

9949

4

0.85

2820

2410

12360

5

0.82

2896

2380

14740

6

0.79

2974

2350

17090

7

0.76

3054

2321

19411

8

0.73

3137

2292

21703

9

0.70

3221

2263

23966

10

0.68

3308

2235

26201

11

0.65

3398

2207

28408

12

0.62

3489

2179

30587

13

0.60

3584

2152

32739

14

0.58

3680

2125

34865

15

0.56

3780

2099

36963

Source: Matrix Study, DG ENTR Calculations

2.3.4 Productivity loss of adult ADHD patient

Table 010; Productivity loss of adult ADHD patient – 2007-12 Euros

 

2007

2008

2009

2010

2011

2012

Productivity loss of adult ADHD patient

€ 19,994

20725

21695

23182

25540

26229

Source: Matrix Study, DG ENTR Calculations

The estimated value of the productivity loss of an adult ADHD patient is estimated to be of 26 229 euros at 2012 prices.



2.3.5 Lifetime QALY loss associated with ADHD in childhood and adulthood

Table 011 Monetary value of a QALY 2007-12

 

2007

2008

2009

2010

2011

2012

Monetary value of a QALY

23,929

24804

25965

27745

30566

31391

Source: Matrix Study, DG ENTR Calculations

Table 012 Lifetime QALY loss associated with ADHD in childhood and adulthood

 

discount factor

Annual QALY loss associated with ADHD in childhood = 0.07

Annual QALY loss associated with ADHD in adulthood= 0.09

Annual QALY loss

CF -Discounted Annual QALY loss

NPV = Σ Discounted Annual QALY loss

Annual QALY loss

CF -Discounted Annual QALY loss

NPV = Σ Discounted Annual QALY loss

0

1.00

0.0700

0.0700

0.0700

0

0.0000

0.0000

1

0.96

0.0700

0.0673

0.1373

0

0.0000

0.0000

2

0.92

0.0700

0.0647

0.2020

0

0.0000

0.0000

3

0.89

0.0700

0.0622

0.2643

0

0.0000

0.0000

4

0.85

0.0700

0.0598

0.3241

0

0.0000

0.0000

5

0.82

0.0700

0.0575

0.3816

0

0.0000

0.0000

6

0.79

0.0700

0.0553

0.4369

0

0.0000

0.0000

7

0.76

0.0700

0.0532

0.4901

0

0.0000

0.0000

8

0.73

0.0700

0.0511

0.5413

0

0.0000

0.0000

9

0.70

0.0700

0.0492

0.5905

0

0.0000

0.0000

10

0.68

0.0700

0.0473

0.6378

0

0.0000

0.0000

11

0.65

0.0700

0.0455

0.6832

0

0.0000

0.0000

12

0.62

0.0700

0.0437

0.7270

0

0.0000

0.0000

13

0.60

0.0700

0.0420

0.7690

0

0.0000

0.0000

14

0.58

0.0700

0.0404

0.8094

0

0.0000

0.0000

15

0.56

0.0700

0.0389

0.8483

0

0.0000

0.0000

16

0.53

0.0700

0.0374

0.8857

0.09

0.0481

0.0481

17

0.51

0.0700

0.0359

0.9216

0.09

0.0462

0.0943

18

0.49

0.0700

0.0346

0.9562

0.09

0.0444

0.1387

19

0.47

0.0700

0.0332

0.9894

0.09

0.0427

0.1814

20

0.46

0.0700

0.0319

1.0213

0.09

0.0411

0.2225

21

0.44

0.0700

0.0307

1.0520

0.09

0.0395

0.2620

22

0.42

0.0700

0.0295

1.0816

0.09

0.0380

0.2999

23

0.41

0.0700

0.0284

1.1100

0.09

0.0365

0.3365

24

0.39

0.0700

0.0273

1.1373

0.09

0.0351

0.3716

25

0.38

0.0700

0.0263

1.1635

0.09

0.0338

0.4053

26

0.36

0.0700

0.0252

1.1888

0.09

0.0325

0.4378

27

0.35

0.0700

0.0243

1.2131

0.09

0.0312

0.4690

28

0.33

0.0700

0.0233

1.2364

0.09

0.0300

0.4990

29

0.32

0.0700

0.0224

1.2589

0.09

0.0289

0.5279

30

0.31

0.0700

0.0216

1.2804

0.09

0.0277

0.5556

31

0.30

0.0700

0.0208

1.3012

0.09

0.0267

0.5823

32

0.29

0.0700

0.0200

1.3211

0.09

0.0257

0.6080

33

0.27

0.0700

0.0192

1.3403

0.09

0.0247

0.6326

34

0.26

0.0700

0.0184

1.3588

0.09

0.0237

0.6564

35

0.25

0.0700

0.0177

1.3765

0.09

0.0228

0.6792

36

0.24

0.0700

0.0171

1.3936

0.09

0.0219

0.7011

37

0.23

0.0700

0.0164

1.4100

0.09

0.0211

0.7222

38

0.23

0.0700

0.0158

1.4258

0.09

0.0203

0.7425

39

0.22

0.0700

0.0152

1.4409

0.09

0.0195

0.7619

40

0.21

0.0700

0.0146

1.4555

0.09

0.0187

0.7807

41

0.20

0.0700

0.0140

1.4695

0.09

0.0180

0.7987

42

0.19

0.0700

0.0135

1.4830

0.09

0.0173

0.8161

43

0.19

0.0700

0.0130

1.4960

0.09

0.0167

0.8327

44

0.18

0.0700

0.0125

1.5084

0.09

0.0160

0.8487

45

0.17

0.0700

0.0120

1.5204

0.09

0.0154

0.8641

46

0.16

0.0700

0.0115

1.5319

0.09

0.0148

0.8790

47

0.16

0.0700

0.0111

1.5430

0.09

0.0142

0.8932

48

0.15

0.0700

0.0107

1.5537

0.09

0.0137

0.9069

49

0.15

0.0700

0.0102

1.5639

0.09

0.0132

0.9201

50

0.14

0.0700

0.0098

1.5738

0.09

0.0127

0.9327

51

0.14

0.0700

0.0095

1.5832

0.09

0.0122

0.9449

52

0.13

0.0700

0.0091

1.5923

0.09

0.0117

0.9566

53

0.13

0.0700

0.0088

1.6011

0.09

0.0113

0.9679

54

0.12

0.0700

0.0084

1.6095

0.09

0.0108

0.9787

55

0.12

0.0700

0.0081

1.6176

0.09

0.0104

0.9891

56

0.11

0.0700

0.0078

1.6254

0.09

0.0100

0.9991

57

0.11

0.0700

0.0075

1.6329

0.09

0.0096

1.0088

58

0.10

0.0700

0.0072

1.6401

0.09

0.0093

1.0180

59

0.10

0.0700

0.0069

1.6470

0.09

0.0089

1.0269

60

0.10

0.0700

0.0067

1.6536

0.09

0.0086

1.0355

61

0.09

0.0700

0.0064

1.6600

0.09

0.0082

1.0437

62

0.09

0.0700

0.0062

1.6662

0.09

0.0079

1.0516

Source: Matrix Study, DG ENTR Calculations

2.4 Number of children aged 1 - 3 years

Table 013 : Evolution in the number of children aged 1 year - 3 years 2007-2012

 

2007

2008

2009

2010

2011

2012F a)

Number of children aged 1 year - 3 years

15270

15448

15629

15870

16057

16260

Source:Eurostat, DG ENTR Calculations

a) forecast for 2012 considering the CAGR for the period 2007-2011

2.5 Total benefit due to reduction in the ADHD prevalence

Table 014 Benefits from the Treatment costs and productivity loss

Treatment costs and productivity loss

2012

Average cost per child a)

Unit

Policy Option 1

Policy Option 2

Lifetime treatment costs of ADHD for child

76,963

351

334

Euros

Lifetime treatment costs of mother caring for child with ADHD

15,918

73

69

Euros

Productivity loss of mother caring for child with ADHD

36,963

169

160

Euros

Productivity loss of adult ADHD patient

26,229

66

63

Euros

Lifetime QALY loss associated with ADHD in adulthood b)

0.848

122

115

Euros

Lifetime QALY loss associated with ADHD in childhood b)

1.052

151

143

Euros

Total benefit per child - at 2012 prices

931

884

Euros

Total benefit due to ADHD (€m) c)

15,134

14,377

MEuros

a) Average cost per total number of child = Total cost per child with ADHD * prevalence rate

b) average value per child = Lifetime QALY loss associated with ADHD * Monetary value of a QALY (31391 euros at 2012 prices)

Considering (a) the adjusted values of the cost used for monetization and (b) the change in the discount rate, the total benefit resulting from a change in prevalence of ADHD will amount to:

15 134 million euros for Policy Option 1, equivalent to a per capita benefit per child of 931 euros

14 377 million euros for Policy Option2, equivalent to a per capita benefit per child of 884 euros.

2.6 Sensitivity analysis on (a) the change in prevalence of ADHD and (b) on the probability childhood ADHD continues into adulthood

The table below shows the different benefits resulting from changes in prevalence of ADHD. As mentioned in 2.2, the unit prevalence of ADHD change per 0.01 change in ug/dl (for > 1.3 ug/dl) was of 0.02282%. The table below allows us to quantify the economic impact of such a change. At a 55% probability rate (the one assumed in the Matrix Study), the expected benefit of such a reduction in prevalence would be 757 million euros (see the highlighted raw). Thus the table provides the monetization of benefits for a very large range depending on changes in prevalence. It shows for instance that the value of preventing 1 626 children from acquiring ADHD would have an impact to the society of at least 321 million euros.

Table 015 - Sensitivity analysis on the change in prevalence of ADHD and on Probability childhood ADHD continues into adulthood

 

No children

%

Probability childhood ADHD continues into adulthood

30.0%

35.0%

40.0%

45.0%

50.0%

55%

60.0%

65.0%

70.0%

Change in prevalence of ADHD

1626

0.01%

321

323

325

327

329

332

334

336

338

3711

0.0228%

732

737

742

747

752

757

762

766

771

5337

0.03%

1053

1060

1067

1074

1081

1088

1095

1102

1109

6963

0.04%

1374

1383

1392

1402

1411

1420

1429

1438

1447

8589

0.05%

1695

1706

1718

1729

1740

1751

1763

1774

1785

10215

0.06%

2016

2029

2043

2056

2070

2083

2096

2110

2123

11841

0.07%

2337

2352

2368

2383

2399

2414

2430

2446

2461

13467

0.08%

2658

2675

2693

2711

2728

2746

2764

2781

2799

15093

0.09%

2979

2998

3018

3038

3058

3078

3097

3117

3137

16719

0.10%

3299

3321

3343

3365

3387

3409

3431

3453

3475

18345

0.11%

3620

3644

3668

3693

3717

3741

3765

3789

3813

19971

0.12%

3941

3967

3994

4020

4046

4072

4098

4125

4151

21597

0.13%

4262

4290

4319

4347

4375

4404

4432

4460

4489

23223

0.14%

4583

4614

4644

4674

4705

4735

4766

4796

4827

24849

0.15%

4904

4937

4969

5002

5034

5067

5099

5132

5165

26475

0.16%

5225

5260

5294

5329

5364

5398

5433

5468

5503

28101

0.17%

5546

5583

5619

5656

5693

5730

5767

5804

5841

29727

0.18%

5867

5906

5945

5984

6023

6062

6101

6140

6179

31353

0.19%

6188

6229

6270

6311

6352

6393

6434

6475

6516

32979

0.20%

6508

6552

6595

6638

6681

6725

6768

6811

6854

34605

0.21%

6829

6875

6920

6965

7011

7056

7102

7147

7192

36230

0.22%

7150

7198

7245

7293

7340

7388

7435

7483

7530

37856

0.23%

7471

7521

7570

7620

7670

7719

7769

7819

7868

39482

0.24%

7792

7844

7896

7947

7999

8051

8103

8154

8206

41108

0.25%

8113

8167

8221

8275

8329

8382

8436

8490

8544

42734

0.26%

8434

8490

8546

8602

8658

8714

8770

8826

8882

44360

0.27%

8755

8813

8871

8929

8987

9046

9104

9162

9220

45986

0.28%

9076

9136

9196

9256

9317

9377

9437

9498

9558

47612

0.29%

9396

9459

9521

9584

9646

9709

9771

9834

9896

49238

0.30%

9717

9782

9846

9911

9976

10040

10105

10169

10234

50864

0.31%

10038

10105

10172

10238

10305

10372

10438

10505

10572

52490

0.32%

10359

10428

10497

10566

10634

10703

10772

10841

10910

54116

0.33%

10680

10751

10822

10893

10964

11035

11106

11177

11248

55742

0.34%

11001

11074

11147

11220

11293

11366

11440

11513

11586

57368

0.35%

11322

11397

11472

11547

11623

11698

11773

11848

11924

58994

0.36%

11643

11720

11797

11875

11952

12030

12107

12184

12262

60620

0.37%

11964

12043

12123

12202

12282

12361

12441

12520

12600

62246

0.38%

12284

12366

12448

12529

12611

12693

12774

12856

12938

63872

0.39%

12605

12689

12773

12857

12940

13024

13108

13192

13275

65498

0.40%

12926

13012

13098

13184

13270

13356

13442

13528

13613

67124

0.41%

13247

13335

13423

13511

13599

13687

13775

13863

13951

68750

0.42%

13568

13658

13748

13839

13929

14019

14109

14199

14289

70376

0.43%

13889

13981

14074

14166

14258

14350

14443

14535

14627

72002

0.44%

14210

14304

14399

14493

14588

14682

14776

14871

14965

73628

0.45%

14531

14627

14724

14820

14917

15014

15110

15207

15303

74217

0.4564%

14647

14744

14842

14939

15036

15134

15231

15328

15426

75843

0.47%

14968

15067

15167

15266

15366

15465

15565

15664

15764

77469

0.48%

15289

15390

15492

15594

15695

15797

15898

16000

16102

79095

0.49%

15610

15713

15817

15921

16025

16128

16232

16336

16439

80721

0.50%

15931

16036

16142

16248

16354

16460

16566

16672

16777

82347

0.51%

16251

16359

16467

16575

16683

16791

16899

17007

17115

83973

0.52%

16572

16682

16793

16903

17013

17123

17233

17343

17453

85599

0.53%

16893

17005

17118

17230

17342

17454

17567

17679

17791

87225

0.54%

17214

17328

17443

17557

17672

17786

17900

18015

18129

88851

0.55%

17535

17652

17768

17885

18001

18118

18234

18351

18467

90477

0.56%

17856

17975

18093

18212

18330

18449

18568

18686

18805

92103

0.57%

18177

18298

18418

18539

18660

18781

18901

19022

19143

93729

0.58%

18498

18621

18743

18866

18989

19112

19235

19358

19481

95355

0.59%

18819

18944

19069

19194

19319

19444

19569

19694

19819

96981

0.60%

19139

19267

19394

19521

19648

19775

19903

20030

20157

98607

0.61%

19460

19590

19719

19848

19978

20107

20236

20366

20495

100233

0.62%

19781

19913

20044

20176

20307

20438

20570

20701

20833

101859

0.63%

20102

20236

20369

20503

20636

20770

20904

21037

21171

103485

0.64%

20423

20559

20694

20830

20966

21102

21237

21373

21509

105111

0.65%

20744

20882

21020

21157

21295

21433

21571

21709

21847

106737

0.66%

21065

21205

21345

21485

21625

21765

21905

22045

22185

108363

0.67%

21386

21528

21670

21812

21954

22096

22238

22380

22523

109989

0.68%

21707

21851

21995

22139

22284

22428

22572

22716

22861

111615

0.69%

22027

22174

22320

22467

22613

22759

22906

23052

23198

113241

0.70%

22348

22497

22645

22794

22942

23091

23239

23388

23536

114867

0.71%

22669

22820

22971

23121

23272

23422

23573

23724

23874

116493

0.72%

22990

23143

23296

23448

23601

23754

23907

24060

24212

118119

0.73%

23311

23466

23621

23776

23931

24086

24240

24395

24550

119745

0.74%

23632

23789

23946

24103

24260

24417

24574

24731

24888

Source: Eurostat

3.    IQ sub-model - Sensitivity analysis 

3.1 Assumptions for parameters for IQ sub-model

Table 01 - Reduction in IQ

 

Value

Ref

Reduction in IQ – 0.2 ug/dl to 0.8 ug/dl

3.9

Lanphear et al (2005)

Reduction in IQ – 0.2 ug/dl to 0.8 ug/dl

5.8

Lanphear et al (2005)

Reduction in IQ – 0.2 ug/dl to 0.8 ug/dl

6.9

Lanphear et al (2005)

Source: Matrix study

Table 02 - Change in IQ due to PO1, Percentage decrease in earnings for a 1 unit decrease in IQ

Unit IQ change per 0.01 ug/dl (for 0.2 ug/dl to 0.8 ug/dl level)

0.01

OBS

Reduction in IQ – 0.2 ug/dl to 0.8 ug/dl)

3.9

/((10ug/dl-2.4ug/dl)/0.01ug/dl)+1)

761

Change in IQ due to PO1

0.1020

2.4 ug/dl)

2.4

(([(BBL PO0 – 2.4 ug/dl)/.01]*(unit change in IQ per 0.01 change in ug/dl) – ((BBL PO1 – 2.4 ug/dl)/.01]*(unit change in IQ per 0.01 change in ug/dl) =( (3.5-2.4)/0.01 * .01) – ((3.3-2.4)/.01 * 0.01) = 0.102

Change in IQ due to PO2

0.097

The change in IQ due to PO2: (IQ PO0 –IQ PO2) = (([(BBL PO0 – 2.4 ug/dl)/.01]*(unit change in IQ per 0.01 change in ug/dl) – ((BBL PO2 – 2.4 ug/dl)/.01]*(unit change in IQ per 0.01 change in ug/dl) =( (3.5-2.4)/0.01 * .01) – ((3.31-2.4)/.01 * 0.01) = 0.097

Percentage decrease in earnings for a 1 unit decrease in IQ

2.00%

Grosse et al (2002)

annual earnings =

€ 21,332

(Eurostat, 2011) adjusted to 2012 at 2,7% inflation

Total lifetime earnings

€ 457,901

See table below

Source: Matrix study

3.2 Total lifetime earnings: annual earnings

Table 03 - Total lifetime earnings: annual earnings

 

discount factor

Annual earnings

CF -Discounted Annual earnings

NPV = Σ Disccounted Annual earnings

0

1.00

21331.82

0

0

1

0.96

21908

0

0

2

0.92

22499

0

0

3

0.89

23107

0

0

4

0.85

23731

0

0

5

0.82

24371

0

0

6

0.79

25029

0

0

7

0.76

25705

0

0

8

0.73

26399

0

0

9

0.70

27112

0

0

10

0.68

27844

0

0

11

0.65

28596

0

0

12

0.62

29368

0

0

13

0.60

30161

0

0

14

0.58

30975

0

0

15

0.56

31812

0

0

16

0.53

32670

0

0

17

0.51

33553

0

0

18

0.49

34458

0

0

19

0.47

35389

0

0

20

0.46

36344

0

0

21

0.44

37326

0

0

22

0.42

38333

0

0

23

0.41

39368

0

0

24

0.39

40431

0

0

25

0.38

41523

0

0

26

0.36

42644

15381

15381

27

0.35

43796

15189

30570

28

0.33

44978

14999

45569

29

0.32

46192

14812

60381

30

0.31

47440

14627

75008

31

0.30

48720

14444

89451

32

0.29

50036

14263

103714

33

0.27

51387

14085

117799

34

0.26

52774

13909

131708

35

0.25

54199

13735

145443

36

0.24

55663

13563

159006

37

0.23

57166

13394

172400

38

0.23

58709

13226

185626

39

0.22

60294

13061

198687

40

0.21

61922

12898

211585

41

0.20

63594

12736

224321

42

0.19

65311

12577

236899

43

0.19

67074

12420

249319

44

0.18

68885

12265

261584

45

0.17

70745

12111

273695

46

0.16

72655

11960

285655

47

0.16

74617

11811

297466

48

0.15

76632

11663

309129

49

0.15

78701

11517

320646

50

0.14

80826

11373

332019

51

0.14

83008

11231

343250

52

0.13

85249

11091

354341

53

0.13

87551

10952

365293

54

0.12

89915

10815

376108

55

0.12

92343

10680

386788

56

0.11

94836

10546

397334

57

0.11

97396

10415

407749

58

0.10

100026

10284

418033

59

0.10

102727

10156

428189

60

0.10

105500

10029

438218

61

0.09

108349

9904

448122

62

0.09

111274

9780

457901

Source: DG ENTR Calculations

Table 04 - Change in lifetime earnings due to reduction in IQ per child

 

Policy option 1

Policy option 2

OBS

Change in lifetime earnings due to reduction in IQ per child

€ 934.12

€ 888.33

a)

Number of children between the age of 2-3 in Europe

16,260

16,260

b)

Total benefit due to IQ (€m)

€ 15,189

€ 14,444

c) = a*b

Source: Matrix study.

Since :

a) Change in lifetime earnings due to reduction in IQ per child = Total lifetime earnings * Percentage decrease in earnings for a 1 unit decrease in IQ * Change in IQ due to PO

the key parameters that influence the total benefit estimated (we are taking as given the reference value for annual earnings and therefore for the lifetime earnings as presented before), are :

Percentage decrease in earnings for a 1 unit decrease in IQ ,

and change in IQ due to policy options

In the next section we will present the expect results of the benefits resulting from changes in these parameters.

3.3 Sensitivity analysis: Percentage decrease in earnings for a 1 unit decrease in IQ, and change in IQ due different policy options.

The table below presents the quantification of the total benefits of preventing a reduction in IQ. A change in IQ from 0.0970 to 0.1020 due to policy options PO1 or PO2, assuming a 2% decrease in earnings for a 1 unit decrease in IQ, would lead to benefits between 14.4 billion euros and 15.1 billion euros. However the table demonstrates that even minor changes in IQ (e.g. 0.0170) and only a minor decline in earnings resulting from the IQ decrease (e.g. 0,80%) will result in significant returns in the scale of 1 billion Euros.

Table 05 Sensitivity analysis: Percentage decrease in earnings for a 1 unit decrease in IQ, and Change in IQ due to Policy Options.

 

Percentage decrease in earnings for a 1 unit decrease in IQ

0.80%

1.00%

1.20%

1.40%

1.60%

1.80%

2.00%

2.20%

2.40%

2.60%

2.80%

3.00%

3.20%

3.40%

3.60%

3.80%

4.00%

Change in IQ due to PO

0.0170

1013

1266

1519

1772

2025

2278

2531

2785

3038

3291

3544

3797

4050

4303

4557

4810

5063

0.0220

1310

1638

1966

2293

2621

2948

3276

3604

3931

4259

4586

4914

5242

5569

5897

6224

6552

0.0270

1608

2010

2412

2814

3216

3618

4021

4423

4825

5227

5629

6031

6433

6835

7237

7639

8041

0.0320

1906

2383

2859

3336

3812

4289

4765

5242

5718

6195

6671

7148

7624

8101

8577

9054

9530

0.0370

2204

2755

3306

3857

4408

4959

5510

6061

6612

7162

7713

8264

8815

9366

9917

10468

11019

0.0420

2502

3127

3752

4378

5003

5629

6254

6880

7505

8130

8756

9381

10007

10632

11257

11883

12508

0.0470

2799

3499

4199

4899

5599

6299

6999

7699

8398

9098

9798

10498

11198

11898

12598

13297

13997

0.0520

3097

3872

4646

5420

6195

6969

7743

8518

9292

10066

10840

11615

12389

13163

13938

14712

15486

0.0570

3395

4244

5093

5941

6790

7639

8488

9337

10185

11034

11883

12732

13580

14429

15278

16127

16975

0.0620

3693

4616

5539

6463

7386

8309

9232

10156

11079

12002

12925

13848

14772

15695

16618

17541

18465

0.0670

3991

4988

5986

6984

7981

8979

9977

10975

11972

12970

13968

14965

15963

16961

17958

18956

19954

0.0720

4289

5361

6433

7505

8577

9649

10721

11794

12866

13938

15010

16082

17154

18226

19298

20371

21443

0.0770

4586

5733

6880

8026

9173

10319

11466

12612

13759

14906

16052

17199

18345

19492

20639

21785

22932

0.0820

4884

6105

7326

8547

9768

10989

12210

13431

14653

15874

17095

18316

19537

20758

21979

23200

24421

0.0870

5182

6477

7773

9068

10364

11659

12955

14250

15546

16841

18137

19432

20728

22023

23319

24614

25910

0.0920

5480

6850

8220

9590

10960

12330

13700

15069

16439

17809

19179

20549

21919

23289

24659

26029

27399

0.0970

5778

7222

8666

10111

11555

13000

14444

15888

17333

18777

20222

21666

23110

24555

25999

27444

28888

0.1020

6075

7594

9113

10632

12151

13670

15189

16707

18226

19745

21264

22783

24302

25821

27339

28858

30377

0.107

6373

7967

9560

11153

12747

14340

15933

17526

19120

20713

22306

23900

25493

27086

28680

30273

31866

0.112

6671

8339

10007

11674

13342

15010

16678

18345

20013

21681

23349

25017

26684

28352

30020

31688

33355

0.117

6969

8711

10453

12196

13938

15680

17422

19164

20907

22649

24391

26133

27876

29618

31360

33102

34844

0.122

7267

9083

10900

12717

14533

16350

18167

19983

21800

23617

25433

27250

29067

30883

32700

34517

36334

0.127

7565

9456

11347

13238

15129

17020

18911

20802

22694

24585

26476

28367

30258

32149

34040

35931

37823

0.132

7862

9828

11794

13759

15725

17690

19656

21621

23587

25553

27518

29484

31449

33415

35381

37346

39312

0.137

8160

10200

12240

14280

16320

18360

20400

22440

24480

26520

28561

30601

32641

34681

36721

38761

40801

0.142

8458

10572

12687

14801

16916

19030

21145

23259

25374

27488

29603

31717

33832

35946

38061

40175

42290

0.147

8756

10945

13134

15323

17512

19701

21889

24078

26267

28456

30645

32834

35023

37212

39401

41590

43779

0.152

9054

11317

13580

15844

18107

20371

22634

24897

27161

29424

31688

33951

36214

38478

40741

43005

45268

0.157

9351

11689

14027

16365

18703

21041

23379

25716

28054

30392

32730

35068

37406

39744

42081

44419

46757

0.162

9649

12062

14474

16886

19298

21711

24123

26535

28948

31360

33772

36185

38597

41009

43422

45834

48246

0.167

9947

12434

14921

17407

19894

22381

24868

27354

29841

32328

34815

37301

39788

42275

44762

47248

49735

0.172

10245

12806

15367

17929

20490

23051

25612

28173

30735

33296

35857

38418

40979

43541

46102

48663

51224

0.177

10543

13178

15814

18450

21085

23721

26357

28992

31628

34264

36899

39535

42171

44806

47442

50078

52713

0.182

10840

13551

16261

18971

21681

24391

27101

29811

32521

35232

37942

40652

43362

46072

48782

51492

54202

0.187

11138

13923

16707

19492

22277

25061

27846

30630

33415

36199

38984

41769

44553

47338

50122

52907

55692

0.192

11436

14295

17154

20013

22872

25731

28590

31449

34308

37167

40026

42885

45744

48604

51463

54322

57181

0.197

11734

14667

17601

20534

23468

26401

29335

32268

35202

38135

41069

44002

46936

49869

52803

55736

58670

0.202

12032

15040

18048

21056

24064

27071

30079

33087

36095

39103

42111

45119

48127

51135

54143

57151

60159

0.207

12330

15412

18494

21577

24659

27742

30824

33906

36989

40071

43153

46236

49318

52401

55483

58565

61648

0.212

12627

15784

18941

22098

25255

28412

31568

34725

37882

41039

44196

47353

50510

53666

56823

59980

63137

ANNEX X

SME TEST

Consultation with

SMEs representatives

During the public consultation, the online questionnaire, hosted on the EU's website, was opened to all categories of economic operators involved in toy manufacturing and marketing. Information on the public consultation was promoted thought different business networks, e.g. Enterprise Europe Network and Toy Industry of Europe. Of the 81 replies received, 56 were submitted by SMEs, representing 70% of the respondents.

Measurement of

the impacts on SMEs

The impacts on SMEs were not measures specifically in each of the options presented. This is because SMEs represents the majority in the toy sector. Statistics shows that of the 2000 companies involved in toy manufacturing and marketing in the EU, most of them are SMEs.

Asses mitigating

measures

Costs on SMEs are expected to be higher than the costs on larger toy manufacturers. However, given the health risks and the range of health costs, they appear as proportionate in relation to the benefits to be obtained. At the end of the impact assessment, there was no indication of a disproportionate burden on SMEs. On the contrary, mitigating measures for SMEs, such as exemptions or longer transitional periods, would have undermined the objectives of the initiative, because SMEs are predominant in the toy sector.



ANNEX XI

Position Paper from Germany regarding the revision of the lead limit values for toys 

Made accessible to the Expert Group meeting of 23 May 2014





ANNEX XII

Further feedback from Germany: Origin of the 2,496 toy samples tested for their content of lead

Made accessible to the Expert Group meeting of 23 May 2014









ANNEX XIII

GLOSSARY

ADHD            Attention Deficit Hyperactivity Disorder

Bioavailability    the amount of each element in the toy which could be absorbed into the systemic circulation of a child

CSTEE    the Scientific Committee on Toxicity, Ecotoxicity and the Environment, an independent scientific committee appointed by the European Commission

EFSA                the European Food Safety Authority

IASG                Impact Assessment Steering Group

Notified Bodies    conformity assessment bodies notified under Directive 2009/48/EC

PVC                Polyvinyl Chloride

QALYs    Quality Adjusted Life Years

RIVM                the Dutch national institute for health and environment

SCHER    the Scientific Committee on Health and Environmental Risks, an independent scientific committee appointed by the European Commission

SMEs                Small and Medium-sized Enterprises

TDI                Tolerable Daily Intake

TFEU                Treaty on the Functioning of the European Union

TSD                the Toy Safety Directive 2009/48/EC

UNEP                United Nations Environment Programme

(1) Scientific Opinion on Lead in Food, EFSA Journal 2010; 8(4):1570
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