Environmental authorization of the pharmaceutical plant in Boecillo modified.

The Department of Agriculture, Livestock, Rural Development and Environmental Policy of the Junta of Castilla y León has modified the environmental authorization of the pharmaceutical production plant located in the municipality of Boecillo (Valladolid), owned by Biotechnology Development for Industry in Pharmaceuticals, S.L., through Order AGR/753/2026, of July 16. The provision is published in the Official Gazette of Castilla y León No. 155, of August 12, 2026, with reference BOCYL-D-12082026-155-11, and incorporates into the authorization the non-substantial modification No. 2 (MNS 2) communicated by the company.

The facility, dedicated to the manufacture of pharmaceutical production and identified with number PRTR 11382, is in operation and is subject to the environmental authorization granted by Order MAV/1575/2022, of November 4, published in the BOCYL on November 21, 2022. According to the file, the authorization had already been the subject of a prior modification (MNS 1) before the one now being processed.

A non-substantial modification with an effect on operation

The holder informed the Department of the projected changes at the facility. On July 8, 2026, the Environmental Prevention and Climate Change Service reported that the notified changes constitute a modification of the installation in accordance with article 14.1 of the Regulation on industrial emissions, given that they affect the operation of the plant. Since none of the criteria determining its substantial nature are met, the changes were considered non-substantial modification No. 2 (MNS 2), and the aforementioned report includes the modifications that must be incorporated into the environmental authorization.

For this classification, the criteria of the following provisions were taken into account:

• article 10.4 of the consolidated text of the Law on integrated pollution prevention and control, approved by Royal Legislative Decree 1/2016, of December 16;
• article 45.2 of the consolidated text of the Environmental Prevention Law of Castilla y León;
• article 14.1 of the Regulation on industrial emissions, approved by Royal Decree 815/2013, of October 18.

A streamlined procedure provided for in environmental regulations

In accordance with articles 10.1 and 10.2 of the consolidated text of the Law on integrated pollution prevention and control and 45.1 and 45.6 of the consolidated text of the Environmental Prevention Law of Castile and León, the modification of activities or installations subject to environmental authorization may be substantial or non-substantial; in this second case, the holder communicates the changes and the authorization is updated by order. The General Directorate of Environmental Policy, in view of the Service’s report, formulated the proposed order that culminated in Order AGR/753/2026, whose publication in the BOCYL is appropriate under the aforementioned provisions.

Signature and appeals

The order was signed on 16 July 2026 in Valladolid by the Minister of Agriculture, Livestock, Rural Environment and Environmental Policy, Joaquín Antonio Pino, and ends the administrative route. Against it, the following may be lodged:

• optional reconsideration appeal within one month from its notification, in accordance with Article 123 of Law 39/2015, of 1 October, on the Common Administrative Procedure of Public Administrations;
• or contentious-administrative appeal before the Administrative Litigation Chamber of the High Court of Justice of Castile and León within two months, in accordance with Law 29/1998, of 13 July, governing the Contentious-Administrative Jurisdiction.

The update keeps the environmental control regime up to date for an operational pharmaceutical facility and, as it is a non-substantial modification, avoids opening a new authorization procedure, which speeds up the adaptation of the activity. For the industrial sector of the province of Valladolid, the publication provides legal certainty and transparency in the environmental processing of a plant of productive relevance.

Source: Boletín Oficial de Castilla y León, No. 155, 12 August 2026, section I.D (Other Provisions), pp. 54-60 (official reference: BOCYL-D-12082026-155-11).