The limit values for arsenic, lead, antimony, barium and mercury set out in the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug — 2. GPSGV) are those laid down in Directive 88/378/EEC, applicable in the EU since 1990. These limits were set out on the basis of scientific evidence available at that time, namely the scientific opinion of the Scientific Advisory Committee to examine the toxicity and ecotoxicity of chemical compounds from 1985, entitled Report EUR 12964(EN), Chapter III ‘Chemical properties of toys’. To set up limit values, estimated food intakes for adults were used as a basis. It was assumed that children, with an estimated body weight up to 12 kg, would have an intake of maximum 50 % of the adults’ intake, and that leaking from toys should not contribute more than 10 %.

The Directive, adopted in 2009, replaced Directive 88/378/EEC and modernised the legal framework applicable to chemicals, by taking into account the latest scientific evidences available at the time of the revision.

The limit values for arsenic, lead, antimony, barium and mercury set out in the Directive are calculated as follows: based on the recommendations of the Dutch National Institute for Public Health and the Environment (RIVM) made in the 2008 report entitled ‘Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on elements’, exposure of children to chemicals in toys may not exceed a certain level, called ‘tolerable daily intake’. Since children are exposed to chemicals via other sources than toys, only a percentage of the tolerable daily intake should be allocated to toys. The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) recommended in its 2004 report that a maximum of 10 % of the tolerable daily intake may be allocated to toys. However, for particularly toxic substances (for example arsenic, lead, mercury) the Legislator decided that the recommended allocation should not exceed 5 % of the tolerable daily intake, in order to ensure that only traces that are compatible with good manufacturing practice will be present. In order to obtain limit values, the maximum percentage of the tolerable daily intake should be multiplied by the weight of a child, estimated at 7,5 kg, and divided by the quantity of toy material ingested, estimated by the RIVM at 8 mg per day for scraped-off toy material, 100 mg for brittle toy material and 400 mg for liquid or sticky toy material. Those ingestion limits were supported by the Scientific Committee on Health and Environmental Risks (SCHER) in its opinion entitled ‘Risks from organic CMR substances in toys’ adopted on 18 May 2010. As the tolerable daily intakes are established by scientific studies, and science may evolve, the Legislator has foreseen the possibility to amend these limits when new scientific evidence is made available.

The Directive establishes migration limits, while the national values Germany wants to maintain are expressed in bioavailability. Bioavailability is defined as the amount of chemicals which actually comes out of a toy and can but may not necessarily be absorbed by the human body. Migration is defined as the amount which actually comes out of a toy and is actually absorbed by the human body. The Commission acknowledges that the bioavailability limits set out in 1990 were transformed in migration limits in standard EN 71-3 — Migration of certain elements. However, calculations made for the purpose of this transformation were approximate. The tolerable daily intakes used are based on recommendations from 1985. A daily intake of 8 mg of toy material was assumed, and adjustments were made to minimise the exposure of children to toxic elements by lowering, for example, the migration limit for barium, and to ensure analytical feasibility by increasing, for example, the migration limit for antimony and arsenic.

The Commission notes that standards are not mandatory, but used on a voluntary basis by industry in the framework on the conformity assessment procedures set out in the legislation. In addition, standard EN 71-3 is currently under revision in order to give presumption of conformity with the new limits values established in the Directive.

In conclusion, different scientific considerations were taken into account when establishing the limits under the Directive and under standard EN 71-3. Those established under the Directive are based on a consistent and transparent scientific-toxicological approach to ensure safety, and can therefore be considered as more appropriate.

Arsenic is a metal naturally occurring in the earth’s crust. It occurs in inorganic and numerous organic forms that differ not only in their physical and chemical properties but also in their occurrence and toxicity. Activities such as mining, waste incineration and wood preservation are the major source for arsenic in the environment. Drinking water and food (in particular seafood) are the main source of human exposure. In toys, traces of arsenic can be found due to the use of natural raw materials which may be naturally contaminated. Arsenic is highly toxic for humans, and can impair the central nervous system, leading to a deterioration of the cognitive functions. Elevated chronic intake of inorganic arsenic may have carcinogenic effects.

The migration limits for arsenic in the Directive are based on the tolerable daily intake established by the Joint Food and Agriculture Organisation/World Health Organisation Expert Committee on Food Additives (JECFA) in 1989, as recommended by RIVM.

The German authorities pointed out that EFSA recommends reducing as far as possible exposure to arsenic, while the limit values for arsenic in scraped-off materials in the Directive increased compared to the limits contained in standard EN 71-3.

Also, Germany underlines that toys are the most significant contribution after food to the overall exposure of children to arsenic.

In conclusion, Germany requests maintaining national limits for arsenic.

The value on which SCHER concluded corresponds to the tolerable daily intake recommended by RIVM and used to calculate migration of arsenic from toys in the Directive. Therefore, the Commission concluded that the limit values for arsenic should not be amended, as no new tolerable intake, which may question the level of protection granted by the Directive, was established.

Furthermore, the Commission would like to stress that the German authorities justified their request to maintain national levels for arsenic by referring to the range of daily intake doses established in the 2009 EFSA study. The Commission notes that the measures notified do not appear consistent with this justification. The limits notified are derived from estimated food intakes established in 1985, not from the doses recommended by EFSA in 2009.

The German authorities further stated that the limits for arsenic in scraped-off materials (47 mg/kg of material) increased compared to the limits established in standard EN 71-3.

The Commission considers that different scientific considerations were taken into account when establishing the limits under the Directive and under standard EN 71-3. Those established under the Directive are based on a consistent and transparent scientific-toxicological approach to ensure safety, and can therefore be considered as more appropriate.

The migration limits for arsenic in scraped-off toy material are based on the tolerable daily intake recommended by RIVM in 2007, and on the assumption that contribution from toys should not exceed 5 %. This percentage was multiplied by the estimated weight of a child (7,5 kg), and divided by the estimated quantity of toy material ingested (8 mg/kg for scraped off materials). The migration limits for arsenic in standard EN 71-3 were derived from the bioavailability limits established in Directive 88/378/EEC, based on estimated food intakes established in 1985. The calculation method applied did not take into account the weight of the child nor the differences between toy materials, as does the Directive. Thus, the Commission considers the limit values established in the Directive as more appropriate.

In the light of the above considerations, the Commission is of the opinion that the measures notified by Germany with regard to arsenic can not be considered as justified on grounds of major need of protection of human health.

Antimony is a semi-metallic chemical element which can exist in two forms, namely metallic and non-metallic form. Antimony occurs naturally in the environment, but also enters the environment through several industrial applications. Antimony is used to make certain types of semi-conductor devices, such as diodes and infrared detectors. Antimony alloys are also used in batteries, low-friction metals, type metal and cable sheathing, among other products. Antimony compounds are used to make flame-proofing materials and paints. Inhalation of antimony can cause irritation of the eyes, skin and lungs. Prolonged exposure can cause lung diseases, heart problems, diarrhoea, severe vomiting and ulcers. In toys, antimony can be used as a flame retardant.

The German authorities noted an increase in the limit values for antinomy in scrapped-off toy materials, as established in the Directive, when compared to the limits contained in standard EN 71-3. Although Germany agrees that no adverse effects on human health are expected from the limits set out in the Directive, this increase is considered as unnecessary. Therefore Germany requests maintaining national limits.

As previously stated, the Commission holds the opinion that the limit values established under the Directive are more appropriate, since they are based on a consistent and transparent scientific-toxicological approach to assure safety.

In addition, the Commission acknowledges that Germany, in the justification brought forward, admits that no adverse effect on human health is expected from the limit values for antimony as established in the Directive. The Commission notes furthermore that Germany did not provide any evidence demonstrating that the Directive does not offer an appropriate level of protection to children, nor that the German measures would assure a higher level of protection.

In the light of the above considerations, the Commission is of the opinion that the measures notified by Germany with regard to antimony can not be considered as justified on grounds of major need of protection of human health.

Barium is present in the earth’s crust, mostly as barium sulphate and barium carbonate. These forms are insoluble in water. Other barium salt such as barium chloride and barium nitrate, however, readily dissolves in water. Barium is present surface water and drinking water (natural occurrence). The barium content in drinking water depends on regional geochemical conditions. Food also contains barium. Ingestion of barium can cause increased blood pressure, stomach irritation, and muscle weakness, damage to the liver, kidney, heart, and spleen. Barium has few industrial applications. As barium naturally occurs in the environment, traces of barium can be found in toys when manufactured with natural raw materials.

The Commission notes that there are uncertainties with regard to the tolerable daily intake for barium. Although human data are considered as a more appropriate basis for deriving a tolerable daily intake, RIVM considered that the studies providing these data contained important flaws. Therefore animal experiments data, more reliable for deriving a tolerable daily intake, were used.

The WHO assessment, based on human data, recommends a lower tolerable daily intake. The Commission recognises that this assessment, likely to offer a higher level of protection to children, may not have been appropriately considered by RIVM.

Thus, the Commission sent a request for an opinion to the SCHER committee, asking for an additional evaluation of the migration limits for barium, and recommendations with regard to the tolerable daily intake to be used, in the light of the WHO assessment document. The opinion is expected to be delivered in March 2012.

Based on the outcome of the SCHER opinion, the Commission may proceed, if deemed necessary, to the revision of the migration limits for barium as established in the Directive.

In the light on the above considerations, the Commission is of the opinion that the measures notified by Germany with regard to barium are considered as justified on grounds of major need of protection of human health.

The German authorities refer to the 2010 EFSA study carrying out a comprehensive assessment on lead. In EFSA’s opinion, there is no scientifically justified threshold dose for the adverse effects of lead on human health. Therefore Germany considers that the migration limits for lead, as established in the Directive, are no longer scientifically based and request maintaining national measures.

The Commission acknowledges that the migration limits for lead as established in the Directive no longer offer an appropriate level of protection for children. The tolerable daily intake used for calculating the limits was questioned by EFSA and JECFA in 2010, after the revision of the toy safety legislation. Taking this into account, the Commission already undertook the revision of the abovementioned limits.

In the light of the above considerations, the Commission is of the opinion that the measures notified by Germany with regard to lead are considered as justified on grounds of major need of protection of human health.

Mercury is a naturally occurring element in the Earth’s crust. The main source of exposure to mercury occurs from dental amalgam. Other sources are drinking water and consumption of fish and other marine organisms. Mercury is also used in fluorescent tubes, batteries and thermometers. Exposure to mercury at critical levels can cause tremors, emotional changes, insomnia, neuromuscular changes, headaches, disturbances in sensations, changes in nerve responses. At higher exposures there may be kidney effects, respiratory failure and death.

Germany notes that the bioavailability limits for mercury established in Directive 88/378/EEC, and consequently in the national measures notified, are 0,5 μg/day, transformed, in standard EN 71-3, in migration limits of 60 mg/kg.

By comparison to the migration limits of mercury in scraped-off materials as established in the Directive (94 mg/kg), Germany concludes to an increase which contradicts the European objective of reduction of human exposure to mercury.

Thus, Germany requests maintaining national measures, regardless of the fact that Germany expects no damage to health from the values established in the Directive.

As previously explained, the Commission holds the opinion that limit values established under the Directive can be considered more appropriate since they are based on a consistent and transparent scientific-toxicological approach to assure safety.

The migration limits for mercury in scraped-off toy material are based on the tolerable daily intake recommended by RIVM in 2007, and on the assumption that the contribution from toys should not exceed 10 %. This percentage was multiplied by the estimated weight of a child (7,5 kg), and divided by the estimated quantity of toy material ingested (8 mg/kg for scraped-off materials). The migration limits for mercury in standard EN 71-3 were derived from the bioavailability limits established in Directive 88/378/EEC, based on estimated food intakes established in 1985. The calculation method applied did not take into account the weight of the child nor the differences between toy materials, as does the Directive. Therefore, the Commission considers the limit values established in the Directive to be more appropriate.

In addition, the Commission acknowledges that Germany, in the justification brought forward, admits that no adverse effect on human health is expected from the limit values for mercury as established in the Directive. In addition, the Commission notes that Germany did not provide any evidence demonstrating that German measures notified would assure a higher level of protection.

In the light of the above considerations, the Commission is of the opinion that the measures notified by Germany with regard to mercury, though based on public health considerations, are considered as not justified on grounds of major need of protection of human health.

Directive 88/378/EEC does not contain specific provisions on nitrosamines and nitrosatable substances. Migration limits were introduced in the Directive for toys intended for children under 3 and other toys intended to be placed in the mouth, applicable as from 20 July 2013. The limits are based on the Scientific Committee on Consumer products (SCCP) opinion from 2007, related to the presence and release of nitrosamines and nitrosatable compounds from rubber balloons.

Germany agrees that the limits set out by the SCCP with regard to balloons are to be considered as posing a negligible risk. However, the German authorities consider that these limits can not be extended to all toys made of synthetic and natural rubber and intended for children under 3, as the exposure parameters are assumed to be different.

SCCP assumed the children are exposed to balloons for 5 hours/year. Germany notes that the mouthing behaviour of children under 3 is assumed to be 3 hours/day. The German authorities concludes that exposure of children under 3 to rubber toys is much higher than exposure to balloons only.

Germany further considers that children are exposed to nitrosamines and nitrosatable substances via all toys made of rubber, regardless of their intended use. Point 8 of Annex II, Part III, to the Directive addresses, in Germany’s opinion, only toys for children under 3 and other toys intended to be placed in the mouth. Thus, Germany invites the Commission to consider enlarging the scope of the Directive in order to include toys which are not intended but likely to be put in the mouth, regardless of the age of the users.

In addition, the German authorities note that, according to the technological state of the art, the formation of nitrosamines and nitrosatable substances during the manufacture of natural or synthetic rubber can largely be avoided by using appropriate vulcanisation accelerators.

In the light of the above justifications, Germany requests maintaining national measures related to nitrosamines and nitrosatable substances in toys for children under 3, intended or likely to be put in the mouth, and made of synthetic or natural rubber.

The Commission notes that the German measures related to nitrosamines and nitrosatable substances were adopted in 2008. At that time, the risk on human health due to exposure of small children to nitrosamines and nitrosatable substances in rubber toys was not addressed by Directive 88/378/EEC. This risk was confirmed by the SCCP in 2007, and addressed by the Legislator within the revision of the abovementioned Directive.

Point 8 of Annex II, Part III, to the Directive prohibits the use of nitrosamines and nitrosatable substances in toys intended for children under 3 and other toys intended to the placed in the mouth, when the migration of substances is equal or higher that 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosatable substances.

These limits are based on the values considered by SCCP, when evaluating exposure to balloons, as posing a negligible risk to health. Due to the lack of realistic data necessary for evaluating exposure to rubber toys, acknowledged by Germany in the justifications put forward, the limit values recommended for balloons were extended to other types of toys likely to contain nitrosamines or nitrosatable substances.

In the absence of precise data, the Commission agrees that, with regard to toys intended to be placed in the mouth, data on children’s mouthing behaviour is more relevant than data on exposure to balloons for assuming exposure parameters.

In addition, the Commission notes that a specific standard is being developed by the European Committee for Standardisation (CEN) for testing the presence of nitrosamines and nitrosatable substances in toys. The Commission is aware that the limits for nitrosamines in finger paints are going to be lowered from 0,05 mg/kg to 0,01 mg/kg within the development of this standard, in order to better take into account children’s exposure. The Commission will ask CEN to consider data on small children’s mouthing behaviour for all toys covered by point 8 of Annex II, Part III, to the Directive.

In the light of the above considerations, the Commission is of the opinion that the measures notified by Germany with regard to nitrosamines and nitrosatable substances in toys for children under 3 and made of synthetic or natural rubber are considered as justified on grounds of major need of protection of human health.

As regards extending the scope of these provisions to toys which are not intended but likely to be placed in the mouth, the Commission notes that such requirement is neither in force in Germany, nor part of the national legislation notified pursuant to Article 114(4). Thus such request can not be considered as admissible pursuant to Article 114(4).

However the Commission considers that the Directive addresses appropriately the categories of toys likely to release nitrosamines and nitrosatable substances. All toys intended for children under 3 are concerned, as these children have a pronounced mouthing behaviour (i.e. tendency to put all products into the mouth, even when this is not intended). Toys for older children are concerned only when intended to be placed in the mouth, as the mouthing behaviour is less relevant than for children under 3. The Commission is aware that children under 3 can be in contact with toys intended for older children. However this risk can be addressed by other means, less restrictive, such as appropriate warnings indicating the toys are not suitable for children under 3. The Directive contains provisions for such warnings.

Article 114(6) requires the Commission to verify that the national provisions notified pursuant to Article 114(4) are not a means of arbitrary discrimination. The absence of discrimination, according to the jurisprudence of the Court of Justice, means that no different treatment should be given to similar situations, nor similar treatment to different situations.

Since the measures related to mercury, arsenic, and antimony are not justified by the need to protect the human health, the Commission does not have to verify whether this condition is satisfied.

The German national measures related to lead, barium, nitrosamines and nitrosatable substances in toys apply without distinction to all products, whether manufactured in Germany or imported from other Member States. Therefore, there is no evidence that the German measures have been used as a means of arbitrary discrimination between economic operators in the EU.

National measures derogating from the provisions of a European directive normally constitute a barrier to trade. Products which can be legally placed on the market in the rest of the EU cannot be placed on the concerned Member State’s market. Article 114(6) intends to prevent that national measures notified under Article 114(4) are applied for inappropriate reasons, and in reality constitute economic measures intended to indirectly protect national production.

Since the measures related to mercury, arsenic and antimony are not justified by the need to protect the human health, the Commission does not have to verify whether this condition is satisfied.

With regard to lead, the Commission agrees that the limit values established in the Directive do no longer offer an appropriate level of protection, since the scientific background for setting the values evolved. Consequently, the Commission undertook a revision of these measures. Thus, the Commission considers that the German request is based on a real concern with regard to children’s health, and does not constitute a disguised restriction on trade between Member States.

With regard to barium, the Commission agrees that the WHO assessment was not appropriately considered by RIVM when recommending a tolerable daily intake. Thus, uncertainties exist with regard to the level of protection offered by the Directive. The Commission asked clarifications to SCHER and will consider, as soon as SCHER has adopted its opinion, the revision of the limits if necessary. Therefore, the Commission considers that the German request is based on a real concerns with regard to children’s health, and does not constitute a disguised restriction on trade between Member States.

With regard to nitrosamines and nitrosatable substances, the Commission agrees that exposure parameters with regard to children’s mouthing behaviour where not appropriately considered when establishing limit values in the Directive. The Commission will require CEN to consider these parameters to lower the limit values within the standardisation process. Thus, the Commission considers that the German request is based on a real concern with regard to children’s health, and do not constitute a disguised restriction on trade between Member States.

Article 114(6) prohibits the approval of any national measure likely to affect the functioning of the internal market. However, this requirement can not be interpreted as prohibiting the approval of all measures likely to affect the functioning of the internal market. All measures derogating from a harmonisation measure constitute a measure that is likely to affect the functioning of the internal market. Thus, the Commission considers that the concept of obstacle to the functioning of the internal market as referred to in Article 114(6) has to be understood as a disproportionate effect in relation to the pursued objective, in order to preserve the useful character of the procedure.

Since the measures related to mercury, arsenic and antimony are not justified by the need to protect the human health, the Commission does not have to verify whether this condition is satisfied.

With regard to lead and barium, the Commission notes that manufacturers, when applying the provisions of the Directive, will be able to market toys in all Member States, except for Germany. Manufacturers are not likely to develop two sets of different toys, but align on the derogating provisions in order to have toys which can be marketed in all Member States. The Commission further notes that the German limits for lead and barium are those that have been applicable in the EU since 1990 on the basis of Directive 88/378/EEC, and therefore can be technically met by manufacturers. Toy manufacturers have confirmed this assumption when expressing their position on the German measures. The Commission has therefore reasons to consider that the effect on the functioning of the internal market is proportionate in relation to the objective of protecting children’s health.

With regard to nitrosamines and nitrosatable substances, the Commission concludes similarly. The German measures on nitrosamines and nitrosatable substances are applicable in Germany since 2008. Manufacturers did not, to the Commission’s knowledge, develop two sets of different toys, but aligned to the German provisions in order to have toys which can be marketed in all Member States. With the entry into application of the Directive, less strict that the German measures, the Commission expects manufacturers to align on the strictest provisions in order to have toys which can be marketed in all Member States. The Commission further notes that meeting the German limits is technically feasible, as manufacturers comply with them since 2008. The Commission has therefore reasons to consider that the effect on the functioning of the internal market is proportionate in relation to the objective of protecting children’s health.