(1)

Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in bovine, ovine and caprine animals. It applies to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof.

(2)

Article 15 of Regulation (EC) No 999/2001 provides that the placing on the market or, if need be, the export of bovine, ovine or caprine animals and their semen, embryos and ova are subject to the conditions laid down in Annex VIII thereto. Point 3.1(a) of Section A of Chapter A of that Annex provides that a Member State which has a national control programme for classical scrapie (‘national programme’) covering all of its territory may submit its national programme to the Commission for approval. Point 3.1(b) of that Section provides that the Commission may approve that national programme if it complies with the criteria laid down in point 3.1(a) of that Section. Point 3.2 of that Section lists the Member States whose national programmes have been approved.

(3)

On 13 September 2016, Slovenia submitted to the Commission a request for approval of its national programme. On 8 January 2017, following requests for further information, Slovenia submitted an amended national programme, providing clarification and further information on certain aspects thereof. That amended national programme should be approved, as it complies with the criteria laid down in point 3.1(a) of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001.

(4)

Point 3.2 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 should therefore be amended in order to add Slovenia to the list of Member States with approved national programmes.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

(1)

Directive 2009/48/EC lays down migration limits for toys or components of toys, for a range of elements, including lead, in dry, liquid and scraped-off toy material. The limits for lead are 13,5 mg/kg, 3,4 mg/kg and 160 mg/kg in each toy material, respectively.

(2)

Those limits were based on the recommendations of the Dutch National Institute for Public Health and the Environment (RIVM) in a 2008 report entitled ‘Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on elements’. The RIVM recommendations were based on the conclusion that exposure of children to lead may not exceed a certain level, called ‘tolerable daily intake’. In that report, a tolerable daily intake of 3,6 microgram per kilogram body weight per day was determined as the toxicological reference value for lead.

(3)

Since children are also exposed to lead from sources other than toys, only a certain percentage of the toxicological reference value should be allocated to toys. In its opinion on the ‘Assessment of the bioavailability of certain elements in toys’, adopted on 22 June 2004, the Scientific Committee on Toxicity, Ecotoxicity and Environment recommended that 10 % of the maximum tolerable intake of lead should be allowed as the maximum contribution from toys. In its opinion on the ‘Evaluation of the Migration Limits for Chemical Elements in Toys’, adopted on 1 July 2010, the Scientific Committee for Health and Environmental Risks (SCHER) concurred with the approach that the uptake of lead from toys should not exceed 10 % of a toxicology-based reference value. Furthermore, since lead is considered particularly toxic, its limits in Directive 2009/48/EC were set at half the level considered safe according to the criteria of the relevant Scientific Committee, in order to ensure that only traces of lead that are compatible with good manufacturing practice should be present. Accordingly, the limits for lead were set in that Directive at 5 % of the tolerable daily intake, determined as the migration of lead from toys.

(4)

The European Food Safety Authority (EFSA) concluded that for lead, as a toxic metal, there is no threshold below which the exposure to lead has no critical health effects. Even low-level exposure to lead may cause neurotoxicity, namely damage to the nervous system and brain, in particular learning deficits. Therefore, according to that new scientific knowledge published by EFSA, the tolerable daily intake should no longer be used as the toxicological reference value.

(5)

According to EFSA, the new toxicological reference to be used for establishing lead limits is the BMDL01 (benchmark dose limit) relating to neurodevelopmental effects. The BMDL01 is the lower confidence limit (95th percentile) of the benchmark dose of a 1 % extra risk of intellectual deficits in children measured by the Full Scale IQ score, that is a decrease in IQ by 1 point on that scale. The BMDL01 is equivalent to a lead intake of 0,5 microgram per kilogram body weight per day.

(6)

The Committee for Risk Assessment established under the European Chemicals Agency agreed with EFSA that the BMDL01 is the highest tolerable exposure for lead. Since the current average blood lead levels in European children are up to four times higher than the highest tolerable exposure level, and since no threshold for the neurodevelopmental effects can be established, any additional exposure must be avoided as far as possible.

(7)

Applying the latest scientific developments to the methodology in the 2008 RIVM report to calculate safe limits for elements in toys and applying the approach of Directive 2009/48/EC in managing the risks of particularly toxic elements such as lead, the limits for lead in toys laid down in Directive 2009/48/EC should be reviewed, and should be set at a 5 % allocation of the BMDL01 for the protection of children's health.

(8)

An erratum to the 2008 RIVM report, published in 2015, considered that the amounts of dry and liquid toy material which children are assumed to ingest, amounts upon which the 2008 RIVM report's recommendations for limit values were based, should be expressed as weekly amounts instead of daily amounts. SCHER subsequently contended that the ingestion amounts originally recommended are appropriate and should continue to be expressed as daily amounts rather than weekly amounts, thereby confirming that the methodology used in the 2008 RIVM report to calculate safe limits for elements in toys is correct. Accordingly, the methodology used in the 2008 RIVM report should continue to be applied for the purposes of laying down revised limits for lead in toys.

(9)

Directive 2009/48/EC should therefore be amended accordingly.

(10)

The committee established under Article 47 of Directive 2009/48/EC delivered no opinion on the measures provided for in this Directive; the Commission therefore submitted to the Council a proposal relating to those measures and forwarded it to the European Parliament,