Merck updates its environmental authorization in Carbajosa de la Sagrada

The Regional Ministry of Agriculture, Livestock, Rural Environment, and Environmental Policy of the Junta de Castilla y León has modified the environmental authorization for the manufacturing and marketing plant of veterinary pharmaceutical specialties of Merck Sharp & Dohme Animal Health, S.L., located in the municipality of Carbajosa de la Sagrada (Salamanca). The decision was adopted via Order AGR/861/2026, of August 27, published in the Official Gazette of Castilla y León (BOCYL) No. 174, of September 8, 2026 (p. 14), as a result of non-substantial modification MNS 50, processed under file 031-26-MNSSA.

The order modifies the environmental authorization originally granted by the Order of April 29, 2008, from the Regional Ministry of the Environment to the then Laboratorios Intervet, S.A., and replaces Annexes I and II under the terms set out in the report from the Environmental Prevention and Climate Change Service. The facility, with code PRTR 03883 and NIF B37012069, carries out its activity across three campuses of the El Montalvo Industrial Estate in Carbajosa de la Sagrada, with an activity classified under CNAE 21.20 (manufacture of pharmaceutical specialties).

Scope of the non-substantial modification

MNS 50 was communicated by the holder on March 11, 2026, and the Environmental Prevention and Climate Change Service issued its favorable report on August 12, 2026. The notified changes are considered non-substantial as they do not increase the impact on safety, health, or the environment, and do not modify or increase emissions, in accordance with Article 10.4 of the consolidated text of the Law on integrated pollution prevention and control and Article 14.1 of the Industrial Emissions Regulation.

The changes incorporated into the authorization are as follows:

• Replacement of equipment Dehydrator 2 (F11) with a dehydrator of similar characteristics.
• Change of burner for the Quality Control Steam Generator (F05).
• Updates to the environmental conditioning of the facility.
• Very small percentage adjustments to production capacity, derived from performance improvements in antigen manufacturing and not from new installations or processes.
• Increase in the estimated production of non-hazardous and hazardous waste, without exceeding the legal margins for it to be considered non-substantial.

Regulatory framework and competent body

The authority to resolve corresponds to the head of the regional ministry for environmental matters, by virtue of Article 19 of the consolidated text of the Environmental Prevention Law of Castilla y León (Legislative Decree 1/2015, of November 12), as amended by Law 4/2024, of May 9. The order, which exhausts administrative remedies, is signed by the regional minister Joaquín Antonio Pino.

The facility has accumulated a history of modifications to its environmental authorization, including changes in ownership (from Laboratorios Intervet to Merck Sharp & Dohme), substantial modification MS 3 (new plot, offices, and solar panels), and numerous non-substantial modifications (MNS 29 to 49) relating to emission sources, boilers, steam generators, warehouses, and quality control buildings.

Relevance to the area

The update of the environmental authorization for this veterinary pharmaceutical plant, one of the benchmark industrial facilities of the El Montalvo Industrial Estate, confirms the continuity of its production activity in Carbajosa de la Sagrada. As it is a non-substantial modification that does not alter emissions, the adjustment of data and production capacity is integrated into the current environmental control regime, without initiating new evaluation procedures. An optional appeal for reversal may be filed against the order within one month, or a contentious-administrative appeal may be filed before the High Court of Justice of Castilla y León within two months.

Source: Official Gazette of Castilla y León, no. 174, September 8, 2026, I. Community of Castilla y León, D. Other Provisions, p. 14 (official reference: BOCYL-D-08092026-174-4).